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Medical Device Risk Management

A course presented over 3 full-days or 5 half-days by Bijan Elahi

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Summary
Course Overview
Course Outline
Video

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.

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 device 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 device 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.

Please note: it is the course participant’s responsibility to purchase the book prior to course participation.

“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 half-day sessions. Delivery dates will be coordinated to best suit your needs.

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, reduces field corrective actions, and achieves significant cost savings to the business.

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 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 estimation
Boolean algebra and quantitative risk computation
Traceability analysis

10. Benefit-Risk Analysis (BRA)

FDA guidance
Criteria for benefit-risk analysis
BRA 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

Best Practices in Risk Management

PPI Course Presenter and Principal Consultant Bijan Elahi, an expert on a world scale in medical device risk management, shares his wisdom in medical device risk management in this interview.

Bijan Elahi is also the author and presenter of PPI’s Medical Device Risk Management training course.