This course is intended to enable the learners to create correct and proper lists of clinical hazards (CHL) and harms (HAL). The CHL and HAL are reusable lists that support risk management of all the products that a company, or a site produces. CHL and HAL are effective labor-saving tools.
RM #102 is intended for R&D, Quality, and Clinical/Medical staff. It is especially important that members of clinical/medical staff receive this training as they provide the competence for the distinction of hazards and harms, and the linkage between the hazards and harms.
The introductory course offers knowledge on the following topics:
Upon completion, participants should:
Duration: 4:00 hours
Language of instruction: English
Means of delivery: In-person, and online via Zoom
About the Instructor
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