Webinar on Traceability and UDI Compliance in Medical Equipment Manufacturing

it's my pleasure to welcome you to today's webinar on traceability and Udi compliance in medical equipment manufacturing this webinar is brought to you by motion Solutions and Omron automation Americas if you have any questions throughout this webinar I invite you to submit them through the question and answer feature we'll get to as many of your questions as possible after the presentation itself for those of you watching uh this webinar on demand we invite you to reach out directly to the motion Solutions engineering sales team through our website with your questions and we'd be pleased to assist you and bring in uh Omron to support us as as appropriate for your solution um with that I'm uh let me introduce myself my name is Peter Hoffman and I'm the vice president of marketing at motion Solutions and I'm pleased to be your moderator for this webinar motion Solutions provides custom application specific engineered systems to oems and Industrial customers in the medical Life Sciences semiconductor and other automation sectors we provide a complete selection of services including electromechanical design prototype and volume manufacturing and engineered services with over 60 years of industrial experience motion Solutions is also a leading distributor of world-class linear motion and motion control products it's now my pleasure to introduce our presenter for this webinar Felix cleb Felix is a marketing manager at Omron automation Americas and he's responsible for sensors Advanced sensing products including barcode readers barcode verifiers RFID systems laser markers Vision systems and Industrial sensors Felix has 25 years of product marketing experience in the area of factory automation equipment most recently Felix with Mike was with micro scan systems which was acquired by Omron in 2017. it's really a pleasure to have Felix uh join us today and present this information Felix is really uh an industry expert and so we're delighted that he'll he's able to join us so with that Felix it's all yours okay thanks Peter and thanks everybody for taking the time to uh learn a little bit more about Udi and medical device labeling this morning and uh barcodes I'm going to go ahead and stop the video so you can focus on the slides um first we'll take a look at a little bit about Omron automation so who is Omron and how did we get involved in the area of Udi you can see here uh some faction figures about Omron and as Peter mentioned uh the way that Omron got involved let's say with Udi and medical device labeling was through the acquisition of microscan in 2017. so I'm coming from the microscan part of the business I sit here at the Home Run micro scan Factory in Renton Washington just outside of Seattle where we produce the barcode readers Machine Vision and the verifiers which we'll also learn a little bit more about the the end of today's presentation so let's take a look at our agenda today our agenda will take us through a high level overview of the Udi labeling requirements as it relates to barcoding of medical device packaging and in some case the medical device itself will follow that with a discussion on a few best practices for label inspection then we'll look at more broadly some of the benefits of implementing traceability Beyond just for Regulatory Compliance and introduce what we at Omron called traceability 4.0 and then finally we'll share some information on Omron hardware and software solutions that help manufacturers comply with the Udi mandate and achieve their other traceability objectives so let's take a look at the high level summary of Udi and barcoding Udi as many of you know stands for Unique device identification and as an FDA mandate first implemented in 2014 it states that for any medical device sold in the U.S there must be a unique ID number issued by an accredited or authorized agency and stored in an FDA database that's applied to the packaging or product labeling of medical devices details on what content the type of barcode the implementation date and other information can be found in FDA provided guidance documents the reason for the Mandate is to help ensure that in the event of a product recall or a field reported problem with medical device there would be a centralized way for impacted parties to easily and quickly identify inventory throughout the supply chain as we'll discuss later beyond the Regulatory Compliance requirements there are benefits to having strong traceability systems within a manufacturing operation in order to deliver these traceability objectives the manufacturer requires accurate and robust equipment that can not only read barcodes but also check their quality to an ISO standard as we'll learn and inspect other information on the product or the package label so let's look into a little more detail on the Udi itself fortunately there are clear guidelines published by the FDA on what is required in terms of information on the product label to comply with the Udi mandate the Udi's final rule was published back in September of 2013 and states that under the Udi rule it must meet the requirements of 21 CFR um part 830.20 requirements for a unique identifier as well as 21 CFR 801.40 which talks about the form of that unique identifier and then finally 21 CFR 81 801.40a specifies that the Udi must be presented in both easily readable plain text and aidc technology forms on the label of the device and on the device package the easily readable plain text form of the EDI should include the device identifier which we also call the DI and the production identifiers which are called the pis while the Udi rule does not require the use of specific forms of aidc Auto ID or specific Technologies to present the Udi the AIDS form of the Udi should be in a format that can be read by a barcode scanner or some other type of aidc Technology the labeler may choose to use more than one type of aidc aidc Technology form to assist users who may be employing different methods of EDI capture technology as an example we could have on that label both a linear barcode and a 2d data Matrix code some readers would only be able to read a linear barcode such as a laser barcode scanner shown on this slide is information from the gs1 who is one of the three accredited issuing agencies for device identifiers the chart cross-references terminology within the FDA Udi rule with terminology used within the gs1 standards within the issuing agency standards are guidelines that further detail the types of barcode symbologies that are acceptable for use the FDA does not stipulate which barcode symbologies must be used so that is within the gs1 standard the type of information that's required are for production identifiers varies by the class of medical device for example class one which is at the lowest risk only requires a DI with pi information being optional 21cfr 801.3 and 801.40 Define which Pi is required based on the class of the medical device Let's uh look a little bit at who is impacted whoever is labeling the product which can include a relabeler such as a company that combines medical multiple medical devices into a kit is one example of who is impacted importers are also impacted as it does not matter where the device was produced if it's sold in the U.S then it must comply with the Udi mandate those who will benefit from a properly marked product include those in the supply chain such as wholesalers and hospitals equipment used in a hospital or medical testing environment such as an in vitro diagnostic device as an example of lab automation equipment impacted by the Udi mandate certain electronic radiation emitting products use the medical applications meet the definition of a medical device examples are diagnostic ultrasound products x-ray machines and medical lasers looking a little bit further at medical device classification as was mentioned earlier both the timelines as well as the type of information that's on the label is impacted by what class your medical device falls into the FDA helps manufacturers determine which class their device would fall into through their database listing device types it's a searchable database that you can see a link to at the bottom of the page uh it's important as I mentioned due to the varying deadlines for Udi implementation and uh also some of the the nuances of labeling requirements in terms of what information has to be on the label so you can see here large database uh lots of different categories um and they are grouped into these 16 panels looking a little bit further at the deadlines you can see that the deadlines for Class 2 and class 3 devices have already passed upcoming deadlines remain for the class 1 devices while the focus of this webinar is the US it's important to note there are similar Udi initiatives happening in Europe with implementation dates beginning next year while there are many similarities in the requirements between the US and Europe there are important differences including that for Europe a notified body must perform the compliance evaluation which then provides the manufacturer with the backup documentation which allows them to put the CE mark on the product and state that they are in compliance with the European medical device regulations and Canada there's a requirement for an identifier very similar to the Udi given a unique number that's assigned to the device by the manufacturer along with the name of the device to be placed on the label foreign let's look at a little bit more detail on the labels themselves here you can see some graphics provided by gs1 that explains the relationship between what's called a G10 global trade identifier number the Udi and the use of Auto ID technology different g10s are required for items which are individually packed and then put into a multi-unit pack then finally a larger case package as shown on the graphic on the lower right of this slide there are guided guidance documents from gs1 on best practices for positioning those labels such they're that they're easily read throughout the supply chain um as was mentioned earlier the FDA has accredited agencies organizations such as gs1 and so that device identifier is in the terminology of uh gs1 what we refer to as a G10 looking a little bit more detail about production identifiers as was mentioned earlier production identifiers for Class 2 and class 3 devices are commonly required here are some examples of the types of information that's embedded for each production identifier in the case of gs1 they use a terminology called AI which is an application identifier to denote these production identifiers I know we're going through a lot of acronyms uh it's important to become familiar with them so those AIS are assigned to each of these data elements so let's take a look at a couple of example labels to get a better handle on what this might look like here you can see a typical label that has a combination of human readable and encoded information within a 2d data Matrix barcode the DI is always at the beginning of the data string and as it was mentioned is called the G10 in the gs1 terminology and now it's followed Then followed by multiple AIS for the production information each AI has a two digit identifier that's specified within the gs1 general specifications looking at a second example you can see more clearly the pi information on the upper right next to the barcode 0 1 is the gs1 identifier for the the G10 or the device identifier followed by the the 17 which is manufacture date the 10 which is the lot number and then 21 which is the individual serial number note that the date format that's encoded in the barcode is not required to have the same format as the human readable text so the FDA does mandate for human readable a four digit year but in the case of the barcoded information you can either use the four digit year or the two digit year as shown there's not a minimum font size for human readable information that's specified by the FDA or gs1 however the FDA through their labeling standards 21cfr 801.15 state that text must be prominent so although that's somewhat of a of a gray area statement in an audit or other a situation where there is a a complaint about unreadable text the FDA could fall back upon that regulation if the font becomes too small to be easily legible okay let's turn a little bit uh on to some specifics around the barcode requirements for Udi compliance so here are some FAQs I've touched on some of these already but we can take a quick look back through them as was mentioned the FDA requires that the Udi info be available both in Auto ID as well as human readable forms on the product label um there are different types of acceptable barcodes and you can find that information within the gs1 general standards so those could be a data Matrix 2D or a type 128 1D code was mentioned uh it could be either in 1D or 2D or an RFID tag we'll talk about RFID in a moment but in general we're not seeing a lot of RFID be used in these types of applications at the unit level the DI must come first in the data stream followed by the pi we touched on that um the Udi should be on every level of packaging except for Logistics unit and for a class one device and those aren't yet impacted a UPC number could serve as the Udi however it still must be registered in the FDA database the good ID database okay let's take a look at an excerpt from the gs1 general specification so I've mentioned the gs1 general specification a couple of times what is the link between Udi compliance and barcode quality that's drilling down a little bit into the details gs1 defines in their General specification several important requirements for barcodes for companies using gs1 as their di issuing agency I will point out here that gs1 has by far the highest market share in the US with I believe over 95 percent of all medical devices registered in the good ID database having a DI that was issued by gs1 so what we're looking at here is way back in the general specification towards the end the tables so in the case of medical devices that are labeled gs1 Table Six is relevant so what we're seeing on the left side of this slide are the different symbologies that are allowed to per gs1 so as I mentioned the data Matrix is possible or the the gs1 128 and and some other codes as well that you list here so the rest of this table gives you important information when it comes to the label design so you have a minimum we call X Dimension so this is the narrow bar width so on a 1D code the uh vertical bars and spaces the narrowest of those are what we would Define as the X Dimension then you can see over a little bit further to the right the allowable barcode sizes so the minimum size for the overall height and width of code the quiet zone so that's the free area without other text printed to the left and to the right or for a 2d above and and below the code as well and then over all the way on the right that I've circled in red here is the barcode quality and what's important to note is that we have a global standard ISO 15415 than ISO one five five four one six that defines how to measure barcode quality and gs1 has information that goes into detail of the calculations you can see here a few numbers so the 1.5 that first number that's over to the left of the circled red field that is the barcode quality the minimum barcode quality of a 1.5 the next two numbers would have to do with the aperture so and the the wavelength of the light so it has to do the testing conditions in General within the gs1 world RFID without a barcode is not acceptable so although you can use RFID there must also be a barcode on the label okay let's um move on in terms of barcode verification so I talked a little bit about that quality that's required in ISO one five four one five ISO one five one five four one six so verification is a method of analyzing a printed barcode um against a published specification that's the iso standard and when we talk about verification we're looking not just at the quality of the barcode we're also looking at the data structure so you may recall earlier we had that string of information with the di and the pis and gs1 has very uh specific codes that you saw earlier for the lot number the serial number the date code Etc and what we're checking with the verifiers to make sure that the structure is compliant with the gs1 general specification so we're checking both the quality of that code to these ISO standards and the data format to the the gs1 standards listed here so contrast that with a barcode reader or scanner a barcode reader or scanner all it will do is tell you that yes this code is readable with that particular Barcode Scanner it does not give you any information about how easy it was or difficult it was to read that code what the quality of the code is or is the day data structure that it read compliant with the the gs1 requirements so benefits of barcode verification why are we doing this well it's certainly part of a label Quality Control process that is required by the FDA so the FDA does not tell you you need to verify every label or verify at a three percent rate but what it does say is that you should have a you must have a quality control system in place around medical device labeling with a barcode verifier you are archiving that testing so you get a test report that you can archive as need be and then use that for audits or other purposes to show conformance to some of these quality inspection requirements and then importantly it also helps pinpoint the cause of label design errors and poor print quality so the whole goal here is is not just to make sure we're compliant but it's to improve the quality of the product and labeling is a very important part of that all right let's uh move a little bit into some best practices around label inspection so first we've talked about verifying and and when should we verify well there's a few points in the process here that we find successful manufacturers are using verification first in the initial label design we want to be able to identify you know very early on potential problems with our label design uh including the barcode design such as that incorrect data structure um what are some sources of potential quality problems in producing that barcode so the quiet Zone uh poor contrast maybe too small of a barcode size so that we're not going to reliably be able to read that barcode throughout the supply chain so that's important in the initial label design that we use a verifier to confirm that what we've designed is going to work well in production and then we move over to the prototyping where we're possibly printing some labels on the equipment that's actually going to be used in production now we have a better handle on issues such as poor contrast based off of the colors used the type of label media what yeah whether it's reflective or a darker label media that may cause that poor contrast and so forth and then finally during production so this is where we're assuring that a product that's going out the door is complying with those gs1 requirements for quality and data structure it could be at the beginning of the label run at the end of a label run or a combination of those or inspecting that 100 level to make sure that every product that's leaving is compliant so this next slide has a short graphic which outlines that process sort of a closed loop at step one was the label design step two was the prototyping that we talked about in the previous slide step three is moving into production and then step four is taking some of that production data after we've produced hundreds or thousands of label labels and analyzing where we run into quality problems and then potentially if it's serious enough going back and adjusting the label design back at step one so we have a variety of solutions which help you work with each of these steps in the process so what are some causes of barcode label and label content defects we've touched on you know the design aspect and a little bit the using of poor poor contrast whether you've got the example here of yellow on white but in production things change right so at the beginning of a roll of ribbon everything looks looks good but you then as as the ribbon starts to get uh old you know you you start to have issues with quality ribbon wrinkle is a potential cause in the thermal printer in a inkjet system you can have clogged inkjets the label substrate may not be consistent so the first roll or two that was used of a print media maybe was fine but then something happened with the supplier of that print media and now you're getting uh some defects so you know a variety of things that can happen through throughout the production process that may cause issues labeling is one of the largest sources of recalls both in medical device as well as Pharmaceuticals so it is a reality that there are issues around labeling that that cause product recalls so looking a little bit more at you know when you're in implementing an inspection system what are some some pitfalls so we've seen manufacturers who maybe are using a very narrow or fine font that becomes difficult to consistently print legibly with adequate boldness so the operator then may turn up the heat settings for example on a thermal printer and that would result in over printing or smudging of the barcode or other information on the label I've touched a little bit about this substrate or the media and what's important to note is that there's specific recommendations from printer manufacturers such as a zebra or Sato or others that recommend specific print ribbon to use with specific media so you may need a different ribbon with a different style of label based off of whether it's a gloss see our polyester versus a more of a map and if you're using the same ribbon for a variety of different label Styles you could run into some trouble using low resolution printers so we find generally that 300 or 600 DPI printers result in the most success as you start to use smaller resolution to a three DPI printers and you combine that with small X Dimension barcodes or small font you're getting poor quality and you you end up failing a lot of labels when it comes to minimum barcode quality and then finally over inspecting so we do have some of our products the ability to look for blemishes on the label and if you set that threshold such that every small blemish is kicking out an error it can slow down production and become very frustrating so making sure that you are only inspecting for errors that truly are having a significant impact on label quality is is a best practice okay um we haven't talked about direct part marks but there are a class of medical devices what we call reprocessable or those that are sterilized and used again um where direct part marking is very common so these are some photos of products so you can see here scissors and so forth where you would typically use a direct part mark and a laser etch so in the case of Omron we have a fiber laser marker which can apply at a very high resolution a a small data Matrix symbol and it's important to note that for this type of device human readable is not required unlike the product label so these would often just have this data Matrix barcode and unlike or like uh label printers you can't have problems with your your direct part mark methods that result in issues here and ultimately degrade the the quality of the the product they need to be able to catch that through a inspection process um I didn't mention earlier but there is a different standard uh ISO standard 29158 and a different table within the gs1 specification table seven which is used for direct part mark inspection and uh compliance okay um let's move over to the broader topic of traceability and what we at Omron called traceability 4.0 so I think most people are aware of the buzz word and you know move towards we call industry 4.0 that's been going on for a number of years and you can see some quotes here uh more recently about traceability being an important part of let's say moving your organization to uh industry 4.0 so you know what is traceability and the evolution of traceability and what do we mean by traceability 4.0 um those of you who've been around barcodes know probably that you know the Inception originally of barcodes was back in the 70s and it was more in the retail space the original barcode was I think on a pack of gum somewhere outside of Dayton Ohio and that was just giving uh enabling we'll call e-commerce so information exchange between the wholesaler and the retailer what that has evolved to in traceability 2.0 was supply chain visibility so uh improving you know lean manufacturing as well was Inventory management throughout the supply chain as we move into traceability 3.0 this got us more into the factory floor with what we call item level visualization so uh production efficiencies tracking of inventory within let's say the walls of the factory et cetera at the line item and unit level visualization and now what is 4.0 4.0 is around process visibility so this relates to you know the terminology big data and what we're trying to do here is to tie production information with uh the ultimate the the quality of the product so we're looking at at the Machine level at the operator level at the at the tool level how are the the quality parameters of the product so if we're 100 testing a product the example would be uh and our label printing operation we may start to get a very good feel for if there's uh 10 label printers which one is producing the best quality when was the last time it was maintained um what types of barcodes are giving us the best quality so it's basically taking a lot of information and improving our ability to fine-tune the the process to improve overall product quality reduce rejects Etc so um this is really the uh where we're at today with with traceability within the walls of the factory so um you know what we find here is we've been out talking with manufacturers is that uh the more enlightened manufacturers you can see a lot of the industries here are using this unit level traceability to improve their overall business long before or even um in addition or beyond what some of the mandates like the Udi initiative is requiring so we want to just encourage that as you're putting traceability into your operations we're extending you're making the investment in the hardware and software let's see you know beyond just complying with the Udi mandate what else can we do to benefit your operations around traceability within the walls of the factory okay um let's spend a moment talking about some of the Omron Solutions so um you can see here some photos of different products some of them are very focused around Udi others are more broadly focused on traceability so uh portable barcode verifiers the left side you see on the lower left we call barcode verifier and it's a typically a handheld or a desk top type situation where we're verifying the information on the individual label a print quality inspection system is the image right above it which shows a zebra zt600 series printer what we have in this product is a line can scan camera right at the discharge of this printer or you can see the label coming out and we'll spend a moment talking about what what that all can give you so that's what we call an inline 100 inspection system so we're inspecting every label as it's produced over on the right we have just your typical fixed barcode readers we also have handheld barcode readers on the upper right RFID system so we didn't talk much about RFID as it relates to the Udi initiative because it's not commonly used but when it comes to traceability we are using RFID within the walls of the factory and often at the case level to monitor products maybe entering one production area versus from another production area and Omron is active in the RFID reader and tag business Vision inspection systems this is more broadly looking at the quality of a product so we've spent a lot of time looking at labeling but what we haven't talked about is you know are all the pieces of that medical device in the proper location you know is a a screw fully inserted whatever it might be so Vision inspection and you can see one of our newer smart cameras up here on the right or towards the top rather lets you look at all the detail of a product and make sure that it is compliant with let's say a golden image or looking for any defects beyond what we're talking about on the label itself and then finally laser markers so I mentioned earlier for direct part mark that there is a technology called fiber laser markers Omron does offer fiber laser markers and it can make very very small marks actually a smaller legible Mark than you would with a typical barcode printer like a thermal transfer printer um just a little bit more detail on the verification report so on the upper left when we use that handheld verifier this is the information you'll get so you may recall when we were looking at that gs1 standard those three numbers separated by the backslash so the overall grade of 2.6 in this case is better than the 1.5 so you know gives you that assurance that you're complying with the the gs1 minimum requirement um and uh gives you the view of the actual label and then down below is sort of an excerpt from the printed report or the report that you'd archive to a PDF or you could export this data in a a flat file for putting it into a database with all of the detail so the ISO standards have a lot of information about how to grade a barcode and on the lower left you can see a lot of these parameters that end up being checked automatically by the barcode verifier so that's the software piece that is doing all the hard work for you automatically and making you aware of any areas that you may have a problem on the upper right is a little bit around the analysis side so this is what we call a 2d or I'm sorry a uh an analysis dimensional analysis showing the reflectance difference between the dark lines in a barcode and the white spaces and as long as we're Crossing this horizontal line called the global threshold we are getting adequate decodability and we call modulation or Edge contrast so if you were to have a trouble with a barcode you would be flagging areas through this analysis where the problem might be and allowing you to make an adjustment in your production event label to um eliminate the problem so uh wrapping it up here you know what are some further resources that you can go to in order to learn more well uh the good news is that both the the FDA as well as gs1 have a a wide variety of documents out on their sites and they're all free where you can learn more so I've put some links here Peter will be sending the the presentation out so you can access these links and there are many many more documents that you can use to help you understand some of those requirements um on the Omron website you'll find some product specific information so I put the what a link here to one of the most popular verifiers the uh lbs 9585 that lets you verify both the printed labels as well as those direct part marks so if you're using direct part marking on your products and labels you then have a single product and Omron does offer assistance both from application evaluation so working with motion Solutions and some of the local Omron experts you can have someone come in and demo a product for you and discuss in specifics some of what your needs are so with that um I think we'll wrap it up and open the the webinar up to some questions fantastic so first of all uh Felix I want to thank you for your really thorough and interesting presentation on this really uh important topic um if you have a question we have a few minutes left uh please go ahead and ask your questions and we'll get to as many of them as we can in these last uh a few minutes that we have available um so Felix I have a few questions that have come in that let me uh send your direction the first is if the regulations change do I have to purchase a new piece of Hardware from your company um I mean that's a that's a great question one thing I would point out is that um the gs1 standards are updated annually So within those gs1 standards you may have a change on an annual basis to some of those application identifiers that we looked at earlier uh Omron does update our software um to reflect the latest gs1 standards and we provide those software updates at no charge so from staying current with the gs1 standards the answer is is no what's difficult to foresee is regulations maybe from the FDA or you know somewhere else that would be uh more far-reaching that you know may require potentially different Hardware an example would be you know today for example we are 95.85 verifier we can verify um a six mil X Dimension uh quite comfortably on a printed label um we do have another version with that goes down closer to a three mil X Dimension um if you had purchased in the past the version that had the six mil X Dimension and FDA for some reason or gs1 said okay we're now going to allow you to go down in our standards to a four mil you know in that case you may have to go back and purchase a different verifier but that is not a very likely scenario so I hope that answers that yeah thank you very much Felix in the presentation you mentioned uh European standards and a question came up uh if if I meet the U us a Udi requirements and I'm shipping to Europe uh do I need to meet the EU regulations um I mean the answer is yes and and the important thing is that the e-regulations although very similar are you know separate from the US so if you've registered with the FDA your products that does not allow you to just ship these to Europe and say you're compliant with the European regulations so the process is you have to work with a notified body if someone like like Tuff or BSI who is essentially taking your your file of information perhaps doing some testing and then issuing a test report that let you put the CE Mark confidently on your product so you do need to go through that process separately with uh for Europe uh a very good thank you um we a couple more questions I'll try to get to in the last few minutes um what's the uh approximate cost of of a label verification system yeah um so it very it varies by what you're trying to do we have as shown the uh all-in-one system with the uh line scan camera built into the printer um so for 100 label inspections inspecting every single label um you know those are in the range of twenty thousand dollars for the uh the hardware and the software and we do offer as well uh installation services on top of that and then for the Standalone um we'll call it the offline system uh lets you with the handheld device uh spot check labels you know those are um in in the range of of seven thousand dollars and and Below uh for a system that includes both the hardware and the software okay thank you very much um one last question and uh we'll call it a wrap uh is is training a part of the purchase and if not you offer training on how to use your label verification system um trainee is typically a separate uh line item that's quoted it depends on the extent of the training the inline uh system with the printer is more involved and we uh would would always uh recommend that someone uh include the the training uh as part of that to make sure it's a successful implementation and for the uh the offline handheld unit we do we do offer training uh both in person and uh remote and that can be uh quoted through motion Solutions fantastic so we're at the end of our time I want to thank again Felix and Omron uh for being such an exceptional partner with motion Solutions uh Felix we appreciate the uh all the the time you put into doing this webinar it was uh some fantastic information if anyone would like more uh assistance with their implementation uh the Udi and traceability please contact promotion Solutions and Omron we look forward to being able to assist you again this webinar will be available on demand uh uh through uh through our website so thank you very much and we hope you have a good rest of your day

it&#39;s my pleasure to welcome you to today&#39;s webinar on traceability and Udi compliance in medical equipment manufacturing this webinar is brought to you by motion Solutions and Omron automation Americas if you have any questions throughout this webinar I invite you to submit them through the question and answer feature we&#39;ll get to as many of your questions as possible after the presentation itself for those of you watching uh this webinar on demand we invite you to reach out directly to the motion Solutions engineering sales team through our website with your questions and we&#39;d be pleased to assist you and bring in uh Omron to support us as as appropriate for your solution um with that I&#39;m uh let me introduce myself my name is Peter Hoffman and I&#39;m the vice president of marketing at motion Solutions and I&#39;m pleased to be your moderator for this webinar motion Solutions provides custom application specific engineered systems to oems and Industrial customers in the medical Life Sciences semiconductor and other automation sectors we provide a complete selection of services including electromechanical design prototype and volume manufacturing and engineered services with over 60 years of industrial experience motion Solutions is also a leading distributor of world-class linear motion and motion control products it&#39;s now my pleasure to introduce our presenter for this webinar Felix cleb Felix is a marketing manager at Omron automation Americas and he&#39;s responsible for sensors Advanced sensing products including barcode readers barcode verifiers RFID systems laser markers Vision systems and Industrial sensors Felix has 25 years of product marketing experience in the area of factory automation equipment most recently Felix with Mike was with micro scan systems which was acquired by Omron in 2017. it&#39;s really a pleasure to have Felix uh join us today and present this information Felix is really uh an industry expert and so we&#39;re delighted that he&#39;ll he&#39;s able to join us so with that Felix it&#39;s all yours okay thanks Peter and thanks everybody for taking the time to uh learn a little bit more about Udi and medical device labeling this morning and uh barcodes I&#39;m going to go ahead and stop the video so you can focus on the slides um first we&#39;ll take a look at a little bit about Omron automation so who is Omron and how did we get involved in the area of Udi you can see here uh some faction figures about Omron and as Peter mentioned uh the way that Omron got involved let&#39;s say with Udi and medical device labeling was through the acquisition of microscan in 2017. so I&#39;m coming from the microscan part of the business I sit here at the Home Run micro scan Factory in Renton Washington just outside of Seattle where we produce the barcode readers Machine Vision and the verifiers which we&#39;ll also learn a little bit more about the the end of today&#39;s presentation so let&#39;s take a look at our agenda today our agenda will take us through a high level overview of the Udi labeling requirements as it relates to barcoding of medical device packaging and in some case the medical device itself will follow that with a discussion on a few best practices for label inspection then we&#39;ll look at more broadly some of the benefits of implementing traceability Beyond just for Regulatory Compliance and introduce what we at Omron called traceability 4.0 and then finally we&#39;ll share some information on Omron hardware and software solutions that help manufacturers comply with the Udi mandate and achieve their other traceability objectives so let&#39;s take a look at the high level summary of Udi and barcoding Udi as many of you know stands for Unique device identification and as an FDA mandate first implemented in 2014 it states that for any medical device sold in the U.S there must be a unique ID number issued by an accredited or authorized agency and stored in an FDA database that&#39;s applied to the packaging or product labeling of medical devices details on what content the type of barcode the implementation date and other information can be found in FDA provided guidance documents the reason for the Mandate is to help ensure that in the event of a product recall or a field reported problem with medical device there would be a centralized way for impacted parties to easily and quickly identify inventory throughout the supply chain as we&#39;ll discuss later beyond the Regulatory Compliance requirements there are benefits to having strong traceability systems within a manufacturing operation in order to deliver these traceability objectives the manufacturer requires accurate and robust equipment that can not only read barcodes but also check their quality to an ISO standard as we&#39;ll learn and inspect other information on the product or the package label so let&#39;s look into a little more detail on the Udi itself fortunately there are clear guidelines published by the FDA on what is required in terms of information on the product label to comply with the Udi mandate the Udi&#39;s final rule was published back in September of 2013 and states that under the Udi rule it must meet the requirements of 21 CFR um part 830.20 requirements for a unique identifier as well as 21 CFR 801.40 which talks about the form of that unique identifier and then finally 21 CFR 81 801.40a specifies that the Udi must be presented in both easily readable plain text and aidc technology forms on the label of the device and on the device package the easily readable plain text form of the EDI should include the device identifier which we also call the DI and the production identifiers which are called the pis while the Udi rule does not require the use of specific forms of aidc Auto ID or specific Technologies to present the Udi the AIDS form of the Udi should be in a format that can be read by a barcode scanner or some other type of aidc Technology the labeler may choose to use more than one type of aidc aidc Technology form to assist users who may be employing different methods of EDI capture technology as an example we could have on that label both a linear barcode and a 2d data Matrix code some readers would only be able to read a linear barcode such as a laser barcode scanner shown on this slide is information from the gs1 who is one of the three accredited issuing agencies for device identifiers the chart cross-references terminology within the FDA Udi rule with terminology used within the gs1 standards within the issuing agency standards are guidelines that further detail the types of barcode symbologies that are acceptable for use the FDA does not stipulate which barcode symbologies must be used so that is within the gs1 standard the type of information that&#39;s required are for production identifiers varies by the class of medical device for example class one which is at the lowest risk only requires a DI with pi information being optional 21cfr 801.3 and 801.40 Define which Pi is required based on the class of the medical device Let&#39;s uh look a little bit at who is impacted whoever is labeling the product which can include a relabeler such as a company that combines medical multiple medical devices into a kit is one example of who is impacted importers are also impacted as it does not matter where the device was produced if it&#39;s sold in the U.S then it must comply with the Udi mandate those who will benefit from a properly marked product include those in the supply chain such as wholesalers and hospitals equipment used in a hospital or medical testing environment such as an in vitro diagnostic device as an example of lab automation equipment impacted by the Udi mandate certain electronic radiation emitting products use the medical applications meet the definition of a medical device examples are diagnostic ultrasound products x-ray machines and medical lasers looking a little bit further at medical device classification as was mentioned earlier both the timelines as well as the type of information that&#39;s on the label is impacted by what class your medical device falls into the FDA helps manufacturers determine which class their device would fall into through their database listing device types it&#39;s a searchable database that you can see a link to at the bottom of the page uh it&#39;s important as I mentioned due to the varying deadlines for Udi implementation and uh also some of the the nuances of labeling requirements in terms of what information has to be on the label so you can see here large database uh lots of different categories um and they are grouped into these 16 panels looking a little bit further at the deadlines you can see that the deadlines for Class 2 and class 3 devices have already passed upcoming deadlines remain for the class 1 devices while the focus of this webinar is the US it&#39;s important to note there are similar Udi initiatives happening in Europe with implementation dates beginning next year while there are many similarities in the requirements between the US and Europe there are important differences including that for Europe a notified body must perform the compliance evaluation which then provides the manufacturer with the backup documentation which allows them to put the CE mark on the product and state that they are in compliance with the European medical device regulations and Canada there&#39;s a requirement for an identifier very similar to the Udi given a unique number that&#39;s assigned to the device by the manufacturer along with the name of the device to be placed on the label foreign let&#39;s look at a little bit more detail on the labels themselves here you can see some graphics provided by gs1 that explains the relationship between what&#39;s called a G10 global trade identifier number the Udi and the use of Auto ID technology different g10s are required for items which are individually packed and then put into a multi-unit pack then finally a larger case package as shown on the graphic on the lower right of this slide there are guided guidance documents from gs1 on best practices for positioning those labels such they&#39;re that they&#39;re easily read throughout the supply chain um as was mentioned earlier the FDA has accredited agencies organizations such as gs1 and so that device identifier is in the terminology of uh gs1 what we refer to as a G10 looking a little bit more detail about production identifiers as was mentioned earlier production identifiers for Class 2 and class 3 devices are commonly required here are some examples of the types of information that&#39;s embedded for each production identifier in the case of gs1 they use a terminology called AI which is an application identifier to denote these production identifiers I know we&#39;re going through a lot of acronyms uh it&#39;s important to become familiar with them so those AIS are assigned to each of these data elements so let&#39;s take a look at a couple of example labels to get a better handle on what this might look like here you can see a typical label that has a combination of human readable and encoded information within a 2d data Matrix barcode the DI is always at the beginning of the data string and as it was mentioned is called the G10 in the gs1 terminology and now it&#39;s followed Then followed by multiple AIS for the production information each AI has a two digit identifier that&#39;s specified within the gs1 general specifications looking at a second example you can see more clearly the pi information on the upper right next to the barcode 0 1 is the gs1 identifier for the the G10 or the device identifier followed by the the 17 which is manufacture date the 10 which is the lot number and then 21 which is the individual serial number note that the date format that&#39;s encoded in the barcode is not required to have the same format as the human readable text so the FDA does mandate for human readable a four digit year but in the case of the barcoded information you can either use the four digit year or the two digit year as shown there&#39;s not a minimum font size for human readable information that&#39;s specified by the FDA or gs1 however the FDA through their labeling standards 21cfr 801.15 state that text must be prominent so although that&#39;s somewhat of a of a gray area statement in an audit or other a situation where there is a a complaint about unreadable text the FDA could fall back upon that regulation if the font becomes too small to be easily legible okay let&#39;s turn a little bit uh on to some specifics around the barcode requirements for Udi compliance so here are some FAQs I&#39;ve touched on some of these already but we can take a quick look back through them as was mentioned the FDA requires that the Udi info be available both in Auto ID as well as human readable forms on the product label um there are different types of acceptable barcodes and you can find that information within the gs1 general standards so those could be a data Matrix 2D or a type 128 1D code was mentioned uh it could be either in 1D or 2D or an RFID tag we&#39;ll talk about RFID in a moment but in general we&#39;re not seeing a lot of RFID be used in these types of applications at the unit level the DI must come first in the data stream followed by the pi we touched on that um the Udi should be on every level of packaging except for Logistics unit and for a class one device and those aren&#39;t yet impacted a UPC number could serve as the Udi however it still must be registered in the FDA database the good ID database okay let&#39;s take a look at an excerpt from the gs1 general specification so I&#39;ve mentioned the gs1 general specification a couple of times what is the link between Udi compliance and barcode quality that&#39;s drilling down a little bit into the details gs1 defines in their General specification several important requirements for barcodes for companies using gs1 as their di issuing agency I will point out here that gs1 has by far the highest market share in the US with I believe over 95 percent of all medical devices registered in the good ID database having a DI that was issued by gs1 so what we&#39;re looking at here is way back in the general specification towards the end the tables so in the case of medical devices that are labeled gs1 Table Six is relevant so what we&#39;re seeing on the left side of this slide are the different symbologies that are allowed to per gs1 so as I mentioned the data Matrix is possible or the the gs1 128 and and some other codes as well that you list here so the rest of this table gives you important information when it comes to the label design so you have a minimum we call X Dimension so this is the narrow bar width so on a 1D code the uh vertical bars and spaces the narrowest of those are what we would Define as the X Dimension then you can see over a little bit further to the right the allowable barcode sizes so the minimum size for the overall height and width of code the quiet zone so that&#39;s the free area without other text printed to the left and to the right or for a 2d above and and below the code as well and then over all the way on the right that I&#39;ve circled in red here is the barcode quality and what&#39;s important to note is that we have a global standard ISO 15415 than ISO one five five four one six that defines how to measure barcode quality and gs1 has information that goes into detail of the calculations you can see here a few numbers so the 1.5 that first number that&#39;s over to the left of the circled red field that is the barcode quality the minimum barcode quality of a 1.5 the next two numbers would have to do with the aperture so and the the wavelength of the light so it has to do the testing conditions in General within the gs1 world RFID without a barcode is not acceptable so although you can use RFID there must also be a barcode on the label okay let&#39;s um move on in terms of barcode verification so I talked a little bit about that quality that&#39;s required in ISO one five four one five ISO one five one five four one six so verification is a method of analyzing a printed barcode um against a published specification that&#39;s the iso standard and when we talk about verification we&#39;re looking not just at the quality of the barcode we&#39;re also looking at the data structure so you may recall earlier we had that string of information with the di and the pis and gs1 has very uh specific codes that you saw earlier for the lot number the serial number the date code Etc and what we&#39;re checking with the verifiers to make sure that the structure is compliant with the gs1 general specification so we&#39;re checking both the quality of that code to these ISO standards and the data format to the the gs1 standards listed here so contrast that with a barcode reader or scanner a barcode reader or scanner all it will do is tell you that yes this code is readable with that particular Barcode Scanner it does not give you any information about how easy it was or difficult it was to read that code what the quality of the code is or is the day data structure that it read compliant with the the gs1 requirements so benefits of barcode verification why are we doing this well it&#39;s certainly part of a label Quality Control process that is required by the FDA so the FDA does not tell you you need to verify every label or verify at a three percent rate but what it does say is that you should have a you must have a quality control system in place around medical device labeling with a barcode verifier you are archiving that testing so you get a test report that you can archive as need be and then use that for audits or other purposes to show conformance to some of these quality inspection requirements and then importantly it also helps pinpoint the cause of label design errors and poor print quality so the whole goal here is is not just to make sure we&#39;re compliant but it&#39;s to improve the quality of the product and labeling is a very important part of that all right let&#39;s uh move a little bit into some best practices around label inspection so first we&#39;ve talked about verifying and and when should we verify well there&#39;s a few points in the process here that we find successful manufacturers are using verification first in the initial label design we want to be able to identify you know very early on potential problems with our label design uh including the barcode design such as that incorrect data structure um what are some sources of potential quality problems in producing that barcode so the quiet Zone uh poor contrast maybe too small of a barcode size so that we&#39;re not going to reliably be able to read that barcode throughout the supply chain so that&#39;s important in the initial label design that we use a verifier to confirm that what we&#39;ve designed is going to work well in production and then we move over to the prototyping where we&#39;re possibly printing some labels on the equipment that&#39;s actually going to be used in production now we have a better handle on issues such as poor contrast based off of the colors used the type of label media what yeah whether it&#39;s reflective or a darker label media that may cause that poor contrast and so forth and then finally during production so this is where we&#39;re assuring that a product that&#39;s going out the door is complying with those gs1 requirements for quality and data structure it could be at the beginning of the label run at the end of a label run or a combination of those or inspecting that 100 level to make sure that every product that&#39;s leaving is compliant so this next slide has a short graphic which outlines that process sort of a closed loop at step one was the label design step two was the prototyping that we talked about in the previous slide step three is moving into production and then step four is taking some of that production data after we&#39;ve produced hundreds or thousands of label labels and analyzing where we run into quality problems and then potentially if it&#39;s serious enough going back and adjusting the label design back at step one so we have a variety of solutions which help you work with each of these steps in the process so what are some causes of barcode label and label content defects we&#39;ve touched on you know the design aspect and a little bit the using of poor poor contrast whether you&#39;ve got the example here of yellow on white but in production things change right so at the beginning of a roll of ribbon everything looks looks good but you then as as the ribbon starts to get uh old you know you you start to have issues with quality ribbon wrinkle is a potential cause in the thermal printer in a inkjet system you can have clogged inkjets the label substrate may not be consistent so the first roll or two that was used of a print media maybe was fine but then something happened with the supplier of that print media and now you&#39;re getting uh some defects so you know a variety of things that can happen through throughout the production process that may cause issues labeling is one of the largest sources of recalls both in medical device as well as Pharmaceuticals so it is a reality that there are issues around labeling that that cause product recalls so looking a little bit more at you know when you&#39;re in implementing an inspection system what are some some pitfalls so we&#39;ve seen manufacturers who maybe are using a very narrow or fine font that becomes difficult to consistently print legibly with adequate boldness so the operator then may turn up the heat settings for example on a thermal printer and that would result in over printing or smudging of the barcode or other information on the label I&#39;ve touched a little bit about this substrate or the media and what&#39;s important to note is that there&#39;s specific recommendations from printer manufacturers such as a zebra or Sato or others that recommend specific print ribbon to use with specific media so you may need a different ribbon with a different style of label based off of whether it&#39;s a gloss see our polyester versus a more of a map and if you&#39;re using the same ribbon for a variety of different label Styles you could run into some trouble using low resolution printers so we find generally that 300 or 600 DPI printers result in the most success as you start to use smaller resolution to a three DPI printers and you combine that with small X Dimension barcodes or small font you&#39;re getting poor quality and you you end up failing a lot of labels when it comes to minimum barcode quality and then finally over inspecting so we do have some of our products the ability to look for blemishes on the label and if you set that threshold such that every small blemish is kicking out an error it can slow down production and become very frustrating so making sure that you are only inspecting for errors that truly are having a significant impact on label quality is is a best practice okay um we haven&#39;t talked about direct part marks but there are a class of medical devices what we call reprocessable or those that are sterilized and used again um where direct part marking is very common so these are some photos of products so you can see here scissors and so forth where you would typically use a direct part mark and a laser etch so in the case of Omron we have a fiber laser marker which can apply at a very high resolution a a small data Matrix symbol and it&#39;s important to note that for this type of device human readable is not required unlike the product label so these would often just have this data Matrix barcode and unlike or like uh label printers you can&#39;t have problems with your your direct part mark methods that result in issues here and ultimately degrade the the quality of the the product they need to be able to catch that through a inspection process um I didn&#39;t mention earlier but there is a different standard uh ISO standard 29158 and a different table within the gs1 specification table seven which is used for direct part mark inspection and uh compliance okay um let&#39;s move over to the broader topic of traceability and what we at Omron called traceability 4.0 so I think most people are aware of the buzz word and you know move towards we call industry 4.0 that&#39;s been going on for a number of years and you can see some quotes here uh more recently about traceability being an important part of let&#39;s say moving your organization to uh industry 4.0 so you know what is traceability and the evolution of traceability and what do we mean by traceability 4.0 um those of you who&#39;ve been around barcodes know probably that you know the Inception originally of barcodes was back in the 70s and it was more in the retail space the original barcode was I think on a pack of gum somewhere outside of Dayton Ohio and that was just giving uh enabling we&#39;ll call e-commerce so information exchange between the wholesaler and the retailer what that has evolved to in traceability 2.0 was supply chain visibility so uh improving you know lean manufacturing as well was Inventory management throughout the supply chain as we move into traceability 3.0 this got us more into the factory floor with what we call item level visualization so uh production efficiencies tracking of inventory within let&#39;s say the walls of the factory et cetera at the line item and unit level visualization and now what is 4.0 4.0 is around process visibility so this relates to you know the terminology big data and what we&#39;re trying to do here is to tie production information with uh the ultimate the the quality of the product so we&#39;re looking at at the Machine level at the operator level at the at the tool level how are the the quality parameters of the product so if we&#39;re 100 testing a product the example would be uh and our label printing operation we may start to get a very good feel for if there&#39;s uh 10 label printers which one is producing the best quality when was the last time it was maintained um what types of barcodes are giving us the best quality so it&#39;s basically taking a lot of information and improving our ability to fine-tune the the process to improve overall product quality reduce rejects Etc so um this is really the uh where we&#39;re at today with with traceability within the walls of the factory so um you know what we find here is we&#39;ve been out talking with manufacturers is that uh the more enlightened manufacturers you can see a lot of the industries here are using this unit level traceability to improve their overall business long before or even um in addition or beyond what some of the mandates like the Udi initiative is requiring so we want to just encourage that as you&#39;re putting traceability into your operations we&#39;re extending you&#39;re making the investment in the hardware and software let&#39;s see you know beyond just complying with the Udi mandate what else can we do to benefit your operations around traceability within the walls of the factory okay um let&#39;s spend a moment talking about some of the Omron Solutions so um you can see here some photos of different products some of them are very focused around Udi others are more broadly focused on traceability so uh portable barcode verifiers the left side you see on the lower left we call barcode verifier and it&#39;s a typically a handheld or a desk top type situation where we&#39;re verifying the information on the individual label a print quality inspection system is the image right above it which shows a zebra zt600 series printer what we have in this product is a line can scan camera right at the discharge of this printer or you can see the label coming out and we&#39;ll spend a moment talking about what what that all can give you so that&#39;s what we call an inline 100 inspection system so we&#39;re inspecting every label as it&#39;s produced over on the right we have just your typical fixed barcode readers we also have handheld barcode readers on the upper right RFID system so we didn&#39;t talk much about RFID as it relates to the Udi initiative because it&#39;s not commonly used but when it comes to traceability we are using RFID within the walls of the factory and often at the case level to monitor products maybe entering one production area versus from another production area and Omron is active in the RFID reader and tag business Vision inspection systems this is more broadly looking at the quality of a product so we&#39;ve spent a lot of time looking at labeling but what we haven&#39;t talked about is you know are all the pieces of that medical device in the proper location you know is a a screw fully inserted whatever it might be so Vision inspection and you can see one of our newer smart cameras up here on the right or towards the top rather lets you look at all the detail of a product and make sure that it is compliant with let&#39;s say a golden image or looking for any defects beyond what we&#39;re talking about on the label itself and then finally laser markers so I mentioned earlier for direct part mark that there is a technology called fiber laser markers Omron does offer fiber laser markers and it can make very very small marks actually a smaller legible Mark than you would with a typical barcode printer like a thermal transfer printer um just a little bit more detail on the verification report so on the upper left when we use that handheld verifier this is the information you&#39;ll get so you may recall when we were looking at that gs1 standard those three numbers separated by the backslash so the overall grade of 2.6 in this case is better than the 1.5 so you know gives you that assurance that you&#39;re complying with the the gs1 minimum requirement um and uh gives you the view of the actual label and then down below is sort of an excerpt from the printed report or the report that you&#39;d archive to a PDF or you could export this data in a a flat file for putting it into a database with all of the detail so the ISO standards have a lot of information about how to grade a barcode and on the lower left you can see a lot of these parameters that end up being checked automatically by the barcode verifier so that&#39;s the software piece that is doing all the hard work for you automatically and making you aware of any areas that you may have a problem on the upper right is a little bit around the analysis side so this is what we call a 2d or I&#39;m sorry a uh an analysis dimensional analysis showing the reflectance difference between the dark lines in a barcode and the white spaces and as long as we&#39;re Crossing this horizontal line called the global threshold we are getting adequate decodability and we call modulation or Edge contrast so if you were to have a trouble with a barcode you would be flagging areas through this analysis where the problem might be and allowing you to make an adjustment in your production event label to um eliminate the problem so uh wrapping it up here you know what are some further resources that you can go to in order to learn more well uh the good news is that both the the FDA as well as gs1 have a a wide variety of documents out on their sites and they&#39;re all free where you can learn more so I&#39;ve put some links here Peter will be sending the the presentation out so you can access these links and there are many many more documents that you can use to help you understand some of those requirements um on the Omron website you&#39;ll find some product specific information so I put the what a link here to one of the most popular verifiers the uh lbs 9585 that lets you verify both the printed labels as well as those direct part marks so if you&#39;re using direct part marking on your products and labels you then have a single product and Omron does offer assistance both from application evaluation so working with motion Solutions and some of the local Omron experts you can have someone come in and demo a product for you and discuss in specifics some of what your needs are so with that um I think we&#39;ll wrap it up and open the the webinar up to some questions fantastic so first of all uh Felix I want to thank you for your really thorough and interesting presentation on this really uh important topic um if you have a question we have a few minutes left uh please go ahead and ask your questions and we&#39;ll get to as many of them as we can in these last uh a few minutes that we have available um so Felix I have a few questions that have come in that let me uh send your direction the first is if the regulations change do I have to purchase a new piece of Hardware from your company um I mean that&#39;s a that&#39;s a great question one thing I would point out is that um the gs1 standards are updated annually So within those gs1 standards you may have a change on an annual basis to some of those application identifiers that we looked at earlier uh Omron does update our software um to reflect the latest gs1 standards and we provide those software updates at no charge so from staying current with the gs1 standards the answer is is no what&#39;s difficult to foresee is regulations maybe from the FDA or you know somewhere else that would be uh more far-reaching that you know may require potentially different Hardware an example would be you know today for example we are 95.85 verifier we can verify um a six mil X Dimension uh quite comfortably on a printed label um we do have another version with that goes down closer to a three mil X Dimension um if you had purchased in the past the version that had the six mil X Dimension and FDA for some reason or gs1 said okay we&#39;re now going to allow you to go down in our standards to a four mil you know in that case you may have to go back and purchase a different verifier but that is not a very likely scenario so I hope that answers that yeah thank you very much Felix in the presentation you mentioned uh European standards and a question came up uh if if I meet the U us a Udi requirements and I&#39;m shipping to Europe uh do I need to meet the EU regulations um I mean the answer is yes and and the important thing is that the e-regulations although very similar are you know separate from the US so if you&#39;ve registered with the FDA your products that does not allow you to just ship these to Europe and say you&#39;re compliant with the European regulations so the process is you have to work with a notified body if someone like like Tuff or BSI who is essentially taking your your file of information perhaps doing some testing and then issuing a test report that let you put the CE Mark confidently on your product so you do need to go through that process separately with uh for Europe uh a very good thank you um we a couple more questions I&#39;ll try to get to in the last few minutes um what&#39;s the uh approximate cost of of a label verification system yeah um so it very it varies by what you&#39;re trying to do we have as shown the uh all-in-one system with the uh line scan camera built into the printer um so for 100 label inspections inspecting every single label um you know those are in the range of twenty thousand dollars for the uh the hardware and the software and we do offer as well uh installation services on top of that and then for the Standalone um we&#39;ll call it the offline system uh lets you with the handheld device uh spot check labels you know those are um in in the range of of seven thousand dollars and and Below uh for a system that includes both the hardware and the software okay thank you very much um one last question and uh we&#39;ll call it a wrap uh is is training a part of the purchase and if not you offer training on how to use your label verification system um trainee is typically a separate uh line item that&#39;s quoted it depends on the extent of the training the inline uh system with the printer is more involved and we uh would would always uh recommend that someone uh include the the training uh as part of that to make sure it&#39;s a successful implementation and for the uh the offline handheld unit we do we do offer training uh both in person and uh remote and that can be uh quoted through motion Solutions fantastic so we&#39;re at the end of our time I want to thank again Felix and Omron uh for being such an exceptional partner with motion Solutions uh Felix we appreciate the uh all the the time you put into doing this webinar it was uh some fantastic information if anyone would like more uh assistance with their implementation uh the Udi and traceability please contact promotion Solutions and Omron we look forward to being able to assist you again this webinar will be available on demand uh uh through uh through our website so thank you very much and we hope you have a good rest of your day

Transcript for:Webinar on Traceability and UDI Compliance in Medical Equipment Manufacturing

Transcript for:
Webinar on Traceability and UDI Compliance in Medical Equipment Manufacturing