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:
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.
The objective of this course is to offer comprehensive and lasting knowledge in many topics, including:
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.
|Interviews – Podcasts (audio)|
|Interviews – Podcasts (video)|
|Articles about Bijan||· 5 Nuggets of Wisdom (2022)|
|Whitepaper||· Quantification of Benefits for Medical Devices|
|Books||· Safety Risk Management for Medical Devices (2nd Edition, 2022) (1st Edition, 2018)|