RM #101- Introduction to Medical Device Safety Risk Management in Compliance with ISO 14971  

Course description:

This introductory course focuses on safety risk management for medical devices, in compliance with ISO 14971.  ISO 14971 is the international standard for the application of risk management to medical devices.

Intended Audience:

The introductory course is aimed at people who have low/no prior experience with risk management of medical devices.  It is suitable for people who will be performing the actual work of risk management, and also for people who will not perform risk management activities themselves but need a general understanding, e.g., Regulatory, Clinical, or management.


The introductory course offers knowledge on the following topics:

  • What is Risk Management?
  • Why is Risk Management important, and why we do Risk Management?
  • Understanding risk, its perception and tolerance
  • Vocabulary & language of Risk Management
  • Is it possible to make a safe device?
  • How do we control risk?
  • Landscape of Risk Management standards
  • Requirements of ISO 14971
  • How risk management can add value to product development

Upon completion, participants should:

  1.    Understand the fundamentals of medical device risk management
  2.  Understand what risk is, and the types of risk
  3.     Become aware of the regulatory landscape with respect to risk management
  4.       Understand the requirements of ISO 14971 for medical device risk management
  5.       Comprehend the terminology and language of risk management
  6.       Become aware of the minimum content for a risk management plan and report
  7.     Understand the different methods of risk reduction and control
  8.     Understand the partnership between risk management and product development, and how risk         management can add value to the product development process

To deepen the learning, there are multiple interactive quizzes and one learning game in this course.

Duration: 4:00 hours

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)

Interviews – Podcasts (video)

Articles about Bijan