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Medical Device Risk Management

A course presented over 2 half-days by Bijan Elahi

(154 Reviews)

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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 the fundamental knowledge for a 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.

The course is presented online in 2 half-days, covering the critical topics that are necessary for risk management per ISO 14971. There are lectures on theory, and quizzes to deepen the learning.

Key Learning Objectives

At the conclusion of this course, participants are expected to have developed a sound, usable 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 and 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.

Course Availability

The course 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

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

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)
Harms Assessment List (HAL)

6. Medical Device Risk Management Tools and Techniques

Fault Tree Analysis (FTA)
Failure Modes and Effects Analysis (FMEA/FMECA)
- Introduction
- Distinction between risk management and FMEA
- Relationship between FMEA and FTA
Usability Engineering and risk management
Use/Misuse FMEA (UMFMEA)

7. Software Risk Management

Introduction
Contribution of software to system hazards
Software risks
Examples of SW faults

8. Cybersecurity and safety risk management

Introduction to cybersecurity management
Connection between cybersecurity and safety risk management

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)
Risk controls, distinction and proper crafting
- Safe by design/manufacture
- Protective Measures
- Information for safety
Traceability analysis

10. Benefit-Risk Analysis (BRA)

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
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.