RM #201 – Advanced Topics

Course description:

This course is a deep dive into several topics in risk management.  It is intended to answer the most difficult questions in medical device risk management.  A sampling of the covered topics:

· Risk Acceptance Policy creation

· What if risk cannot be estimated?

· Reliability effect on safety

· Risk management process metrics

· Critical thinking and risk management

· Traceability for audit-readiness

· Automation and quantitative methods

· Risk controls crafting & distinctions

· Verification of risk controls

· Device lifetime determination

· Risk-based design verification testing

· What good looks like in risk management

· Strategies for designing safety into systems

· Use of risk mgmt to identify Essential Performance

The covered topics in this course are dynamic and vary.

Intended Audience:

Risk Management 201 is aimed at people who have significant prior experience with risk management for medical devices. It is suitable for people who will be involved in producing risk management documents; experts in risk management, and those who wish to get a deep understanding of risk management in compliance with ISO 14971.


Th objective for RM #201 is to deepen the knowledge of risk management experts, and shine light in the dark corners of knowledge.  Ultimately this knowledge would help the experts navigate the difficulties in risk management that everyone will face at some point.

Upon completion, participants should:

Have a strengthened sense of confidence and deeper knowledge in risk management of medical devices.


Duration: 2-3 hours, depending on the number of topics covered.

Language of instruction: English

Means of delivery: In-person, and online via Zoom

CEU: ASQ and CSQE certified professionals can receive CEUs. Ask for a certificate of attendance.

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)

· ISO 14971; What’s difficult about risk mgmt; Quantitative risk mgmt; AFAP … (2023)

· Risk Management – Aerospace to Medical Devices; Uncommon Knowledge (2023)

· Risk-Based Decision Making (2023)

Interviews – Podcasts (video)

· Risk management for software – SaMD (2023)

· Wisdom of Risk Management (2022)

Articles about Bijan

· 5 Nuggets of Wisdom (2022)


· Quantification of Benefits for Medical Devices


· Safety Risk Management for Medical Devices (2nd Edition, 2022) (1st Edition, 2018)