Course Overview:

Medical Devices Risk Management (MDRM) is a progressively more prominent topic in the medical device industry. Regulatory bodies’ expectations of medical device companies in producing quality, logical and defensible risk management files is rising. It is incumbent on the medical device manufacturers to convince the Regulatory bodies that the benefits of a medical device outweigh its risks.  This is especially difficult for complex medical devices.

RM #3D is a course that teaches a practical, disciplined and systematic approach to the analysis, estimation, evaluation, and control of safety risks of medical devices. There are multiple quizzes, and hands-on workshops on the techniques of medical devices risk management, such as fault tree analysis and failure modes and effects analysis.  The course also includes a learning game to deepen the learning, while making learning more enjoyable.

Special topics such as software risk management, cybersecurity, benefit-risk analysis and post-market surveillance are also covered in this course.

This course is the equivalent of a university graduate course taken by doctoral students in engineering.

This course will benefit:

• Practitioners of medical device risk management –risk managers, systems engineers, design engineers, manufacturing engineers, quality engineers, usability engineers, …
• Evaluators of medical devices risk management – quality assurance, management, regulatory staff, …
• People with a need for general understanding of medical devices risk management – clinical, marketing, packaging, toxicology, …

Participants are not expected to have prior knowledge or experience with medical device risk management, but experience in medical device development would be an advantage.

Course Method and Materials:

The training is delivered using a balanced combination of lectures on the theory, and hands-on workshops to practice the just-learned theory. The focus is on deep and lasting learning that the learners can take away and put to immediate use in their workplaces.

The participants are provided with a complete package including presentation materials, electronic templates, and a copy of the best-selling book: Safety Risk Management for Medical Devices, authored by the course instructor and published by Elsevier Publishing under the label of Academic Press. The book is a handy reference and handbook to the practitioners of risk management.

Training Objectives:

The objective of this course is to offer comprehensive and lasting knowledge in many topics, including:

• Vocabulary and terminologies of risk management
• How to establish that risks of a medical device are reduced as far as possible (AFAP)
• How to establish that the benefits of a medical device outweigh its risks
• Software risk management
• Usability engineering as related to safety risk management
• Closing the loop from post-market risk management to pre-market risk management
• The connection between FMEAs and risk management
• How to determine when to stop risk reduction

Course Syllabus:

1. Introduction to Medical Device Risk Management

• Why do we need to do medical device risk management?
• The benefits of medical device risk management
• History and origins of risk management
• Safety constraints
• Language of risk management
• Hazard theory
• Hazard Taxonomy
• How to identify reasonably foreseeable misuses

2. Medical Device Risk Management Standards

• ISO 14971 – the central standard in medical device risk management
• Risk management system
• Risk management process
• Requirements of ISO 14971
• Connections of ISO 14971 to: IEC 60601-1, IEC 62366, IEC 62304, ISO 10993, ISO 14155

3. Medical Device Risk Management as a Value-Added Activity

• How to use risk management to add value to product development

4. Medical Device Risk Management Activities and Artifacts

• Risk management plan
• Risk management report
• Risk management file
• Risk management process
• Risk analysis, evaluation, control and monitoring

5. Foundations for Medical Device Risk Management

• Clinical Hazards List (CHL)
  • What it is
  • How to create it
• Harms Assessment List (HAL)
  • What it is
  • How to create it (two methods)

6. Medical Device Risk Management Tools and techniques

• Fault Tree Analysis (FTA)
  • Introduction
  • FTA workflow
  • Example FTA
• Failure Modes and Effects Analysis (FMEA/FMECA)
  • Introduction
  • Distinction between risk management and FMEA
  • Relationship between FMEA and FTA
  • How to leverage FMEAs to determine Essential Design Outputs (EDOs)
  • Domains of Severity, Occurrence and Detectability
  • Risk management scaling via hierarchical-multi-level FMEA
  • DFMEA
  • PFMEA
• Usability Engineering and risk management
• Use/Misuse FMEA (UMFMEA)
  • Use failure distinctions
  • UMFMEA

7. Software Risk Management

• Introduction
• Software failure model
• Language of SW risk management
• Contribution of software to system hazards
• Software risk
• Examples of SW faults
• Software FMEA

8. Cybersecurity and safety risk management

• Introduction to cybersecurity management
• Connection between cybersecurity and safety risk management
• Strategies for improving safety via cybersecurity

9. Medical Device Risk Assessment

• Preliminary Hazard Analysis (PHA)
• Risk Assessment and Control Table (RACT)
• Risk integration (FMEA, FTA, CHL, HAL, Risk Controls, Risk estimation & evaluation)
• RACT workflow
• P1 and P2, in-depth review
• Risk controls, distinction and proper crafting
  • Safe by design/manufacture
  • Protective Measures
  • Information for safety
• Risk controls end-point logic (when to stop risk reduction)
• Verification of risk controls
• Residual risk rstimation
• Boolean algebra and quantitative risk computation
• Traceability analysis

10. Benefit-Risk Analysis

• FDA guidance
• Criteria for benefit-risk analysis
• FDA decision-making factors

11. Risk Management Review

• Requirements for risk management review
• Outcomes from risk management review

12. Post-market Medical Device Risk Management

• Basis and intention for post-market risk management
• Elements of post-market risk management
• Listening systems
• Surveillance
• Data monitoring
• Complaint handling
• Connection between post-market and premarket risk management

13. In Closing

• Common mistakes in medical device risk management
• Tips and wisdom for success

About the Instructor

Award winning, international educator, consultant, and author

Bijan Elahi has worked in risk management for medical devices for over 30 years at the largest medical device companies in the world, as well as small startups.  He is a Technical Fellow, and the Medtronic corporate Advisor on safety risk management of medical devices.  In this capacity, he offers education and consulting on risk management to all Medtronic business units, worldwide.  Bijan is a lecturer at Eindhoven University of Technology (Netherlands), where he teaches risk management to doctoral students in engineering.  At the invitation of the FDA, he teaches a graduate course on medical device risk management at Drexel University (Philadelphia, USA).

Bijan Elahi is the founder of MedTech Safety, Inc., an education and advisory company. He has educated over 10,000 individuals worldwide with outstanding results.  Bijan is a frequently invited speaker at international professional conferences, and is also a contributor to ISO 14971, the international standard on the application of risk management to medical devices. He is the author of the best-selling book: Safety Risk Management for Medical Devices, published by Elsevier publishing.