Course description:

This introductory course is intended for executives who need to have a general understanding of medical device risk management. The course provides and introduction to risk management in compliance with ISO 14971, the international standard for the application of risk management to medical devices.  The course also provides a section on critical thinking and decision making, and concludes with lessons learned and tips & advice.

This course is highly interactive and engaging for the learners. To deepen the learning, there are multiple interactive quizzes and one learning game in this course.

Intended Audience:

This course is intended for management, and executives who make the hard decisions for the manufacture of medical devices.  They need to have sufficient understanding of the discipline of risk management to efficiently communicate with the product development teams, and the regulators.  

Objective:

The introductory course offers knowledge on the following topics:

• What is medical device risk management?
• Why is risk management important, and why we do risk management?
• The scope of risk management
• Vocabulary & language of risk management
• Is it possible to make a safe device?
• Landscape of risk management standards
• Requirements of ISO 14971
• Best practices in risk management
• Connection and differentiation of pre/post market risk management
• Risk-reduction end-point logic to determine AFAP
• A flowchart for decision making on field corrective actions
• How risk management can add value to product development
• Critical thinking, and barriers to sound decision making
• Lessons learned, and tips & advice

Upon completion, participants should:

1. Understand the fundamentals of medical device risk management
2. Understand the expectations from top management per ISO 14971
3. Become more confident in decision making related to medical device risk management

Course duration: 3:30 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.