AMA Risk Management Webinar - Medical Devices

Introduction

• Host: Lola, Senior Quality Specialist at Qualo
• Guest Speaker: Peter Sellus, founder and head trainer of Medical Device HQ, member of Joint Working Group for ISO 14971
• Focus: Risk management for medical devices
• Agenda: Presentation by Peter based on pre-received questions, followed by live Q&A
• Important Notes:
  • Stay generic in questions for broad benefit
  • Unanswered questions will be covered in a blog post
  • Webinar recording and additional resources to be emailed post-event

Medical Device HQ Overview

• Founded: 2008 by Peter Sellus
• Mission: Efficient development and market entry for medical devices
• Offerings: Training courses, templates, coaching
• Courses: Risk management, clinical investigations, software development, and usability engineering
• Formats: Online or blended (online + virtual classes)
• Resources: Articles and guides (e.g., Illustrated Guide to Quality Management and ISO 13485)

Risk Management Overview and Key Topics

Q1. Clinical Expertise & Definitions

• When is a clinical expert required?

  • No clear ISO or MDR definition; competence required for risk management tasks
  • Essential for transitioning from hazardous situation to harm estimation
  • Importance of clinician involvement in P2 estimation (probability from hazardous situation to harm)
  • Clinicians like physicians, nurses, etc. are preferred

• Definition of Clinical Expert:

  • No clear definition in medical device standards
  • Typically, includes physicians, medical doctors, nurses, dentists, physiotherapists, etc.

Q2. Relevance of ISO 31000 in Medical Devices

• ISO 31000: Guidelines for risk management, applicable to any organization size, activity, or sector

• Key Difference: Definition of risk

  • ISO 14971: Product safety risk (focus on harm)
  • ISO 31000: Broader risk definition including opportunities (positive risk)

• Application in Medical Devices:

  • Avoid mixing definitions between ISO 14971 and ISO 31000
  • Key Advice: Use ISO 14971 product safety risk management for medical devices; use ISO 31000 for broader corporate risk management

Q3. Use of FMEA in Risk Management

• Risk Management (ISO 14971) vs. FMEA (ISO 60812):

  • ISO 14971: Starts with hazards, covers all risks
  • FMEA: Starts with part/process failure, aims to improve reliability, addresses fault conditions

• When to Use FMEA:

  • Products where safety depends on reliability (e.g., essential performance like in pacemakers)
  • Contract manufacturers without clinical consequence info
  • Key Point: Always integrate FMEA insights into ISO 14971 risk evaluations

Q4. Common Mistakes in Risk Management

• Major Mistake: Using only one harm/severity/PO per hazardous situation
• Proper Approach: Consider multiple severities, harms, and probabilities for each hazardous situation
  • Example: Electrical shock severity ranging from minor to lethal
  • Guidance: ISO/TR 24971 supports multiple scenarios
  • Impact: Correct risk table entries for comprehensive risk evaluation

Q5. Origin of Warnings

• Should all warnings stem from risk analysis? Yes.
  • Why: Information for safety (e.g., warnings, IFU instructions) is a risk control measure
  • Requirement: All hazards and hazardous situations must be identified in the risk analysis
  • Precautions: Include risks related to property/environment

Q6. Risk Reduction Requirements

• MDR/IVDR Clause: Reduce risks as far as possible without adversely affecting the benefit-risk ratio
• **Comparison with ISO 14971: **
  • ISO 14971: No specific risk magnitude criteria, requires systematic risk evaluation
  • Documentation: Include both risk magnitude and