ISO 14971 Education - Training - Consulting
Risk management can be confusing
We offer several courses on risk management in compliance with ISO 14971. You will gain practical, beneficial knowledge and skills that you can put to use immediately. Learn how to do risk management in a sensible efficient way and produce great submissions.
Testimonial: "The course on Safety Risk Management with Bijan Elahi gives you a good understanding of the complete risk management process needed for a medical device. You get hands on experience on how to perform risk analysis and how to document your process so you are in compliance with ISO 14971. I would recommend this course to anyone interested in learning (more) about Safety Risk Management for medical devices." -- Novo Nordisk
Do you want answers to your specific questions?
You may know how to perform risk management, but are stuck on a hard question. Or you may want us to facilitate your team's work sessions for faster and higher quality outcomes. Our consulting services will meet your needs.
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Hands-On experience
Workshops
Training courses are delivered worldwide, in-person and online. Courses include workshops and quizzes to deepen the learning and enable the participants to take away practical hands-on experience that is immediately usable in their daily work.
Our courses are engaging, interactive, and fun! We believe when the learners enjoy the course, they take away long-lasting knowledge.
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Bijan Elahi - Educator & Advisor
Bijan Elahi has worked in safety risk management for medical devices for over 29 years at the largest medical device companies in the world, as well as small startups. He started his work in risk management in aerospace; last working on the Space Shuttle at NASA before transitioning to the medical device industry. Passionate about risk management, Bijan has trained over 7,000 people worldwide, on the best practices and knowledge on medical device safety risk management.
Bijan is a technical fellow and corporate advisor on product safety risk management at Medtronic. In this capacity, he offers education and consulting on risk management to all Medtronic business units worldwide. Bijan is also a lecturer at Drexel University in the USA, and Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. 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.
Video - Interview with Bijan: Wisdom of Risk Management
Article about Bijan - 5 Nugget of wisdom
Article about Bijan - All you want to know about risk management and medical devices
Audio Podcast: Risk Management for Clinical Investigators
Book: Safety Risk Management for Medical Devices - Second Edition
Safety Risk Management for Medical Devices demystifies risk management, providing clarity of thought and confidence to the practitioners of risk management as they do their work. Written with practicing engineers, safety management professionals, and students in mind, this book will help readers tackle difficult questions, such as how to define risk acceptance criteria, or how to determine when to stop risk reduction.
This book delivers not only theory, but also practical guidance for applying the theory in daily risk management work. The reader is familiarized with the vocabulary of risk management and guided through a process to ensure compliance with the international standard ISO 14971 – a requirement for all medical devices. This book outlines sensible, easily comprehensible, and state-of-the-art methodologies that are rooted in current industry best practices.
You can purchase the book, Safety Risk Management for Medical Devices from all major sources worldwide. Amazon Elsevier Publishing
Testimonials
“The text, Safety Risk Management for Medical Devices, is an excellent companion for the medical device developers and entrepreneurs. As part of our lean start-up strategy we wanted to complete as much of the development in-house as possible. Elahi’s methods and resources enabled first-timers, such as ourselves, to implement a robust evidence-based risk management approach that supported the successful CE mark of our device.”
-- Devakar Epari (Associate Professor in Biomedical Engineering at Queensland University of Technology, Australia, Co-inventor and developer of the Biphasic Plate)
"Reading and untangling ISO standards is time consuming and daunting. Elahi untangles Risk Management in a comprehensive and thorough manner. He provides clear and precise definitions, interprets unclear sections of the standards, provides templates and step by step directions on how to perform analysis of complex medical devices. He also warns where people tend to get tripped up and lays down ground rules to keep the analysis from getting out of control and keeping progress moving forward. I found the book invaluable. " --Mike Faltys, Amazon
" If you work in the medical device field, either in design or safety, this book is a definite required read." -- Clifton Ericson, Author, Amazon