Course Summary

Medical Devices Risk Management (MDRM) is a progressively more prominent topic in the medical device industry. Expectations by Regulatory bodies of medical device companies in producing quality, logical and defensible risk management files is rising. Manufacturers must convincingly demonstrate that the benefits of their medical devices outweigh the risks. 

This course provides a disciplined, systematic approach to analyzing, estimating, evaluating, and controlling safety risks related to medical devices. The methodology is explainable, logical, and integrated, utilizing formal risk management techniques to predict and prevent serious harm to patients and financial losses to businesses.

Participants will receive a comprehensive introduction to the essential topics for successfully managing safety risks of medical devices, in conformance with the international standard ISO 14971.

Course Overview

The course is designed in multiple sections covering the critical topics that are necessary for risk management per ISO 14971.  There are lectures on theory, multiple quizzes, and hands-on workshops to practice the techniques of medical devices risk management, such as fault tree analysis, and failure modes and effects analysis.  Special topics such as medical device software risk management, and cybersecurity are also addressed in this course.

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

Key Learning Objectives

At the conclusion of this course, participants are expected to have developed a sound working knowledge of medical devices risk management in compliance with ISO 14971.

Training Methods and Materials

Participants are provided with a copy of the presentation materials. templates, and reference resources. 

 The companion textbook, “Safety Risk Management for Medical Devices” authored by the course facilitator is recommended for course participants. The book provides a substantial amount of additional materials, details, and step-by-step instructions on how to perform many of the presented risk management techniques. The book may be purchased from all major booksellers, e.g., Amazon, or directly from the publisher.

https://shop.elsevier.com/books/safety-risk-management-for-medical-devices/elahi/978-0-323-85755-0 

“The text, Safety Risk Management for Medical Devices, is an excellent companion for the medical device developers and entrepreneurs. As part of our lean start-up strategy we wanted to complete as much of the development in-house as possible. Elahi’s methods and resources enabled first-timers, such as ourselves, to implement a robust evidence-based risk management approach that supported the successful CE mark of our device.”

– Devakar Epari, Associate Professor in Biomedical Engineering (QUT), Co-inventor and developer of the Biphasic Plate

Who Should Attend this Course?

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

Participants will not need prior knowledge or experience with medical device risk management, but experience in medical device development would be advantageous.

Do you Offer Tailoring of this Course?

Yes. A certain amount of tailoring is done to emphasize parts of the course that are of more interest to your team.  We can also work with you to create customized training that is optimally suited to the needs of your company.  

Course Availability

This course is available in a 3-Day in-person format.  Online delivery is tailored for 5-halfday sessions. Delivery dates will be coordinated to best suit your needs.

Course Outline

The Value Proposition for World Class Medical Device Risk Management

Proper risk management is a value-adding activity to medical device product development.  Efficient, intelligent, and effective risk management ensures smooth product approvals, reduced field corrective actions, and achieves significant cost savings to the business.

Course Syllabus:

• 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

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

Medical Device Risk Management as a Value-Added Activity

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

Medical Device Risk Management Activities and Artifacts

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

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)

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 

Software Risk Management 

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

Cybersecurity and safety risk management

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

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 estimation
• Boolean algebra and quantitative risk computation
• Traceability analysis

Benefit-Risk Analysis (BRA)

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

Risk Management Review

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

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 

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 safety 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 an affiliate professor at Drexel University, school of biomedical engineering.  Passionate about risk management, Bijan has trained over 10,000 people worldwide, on the best practices and knowledge on medical device safety risk management. 

For more details, please visit MedtechSafety.com