MedTech Safety

Everything about Medical Device Risk Management

ISO 14971 Education - Training - Consulting




Risk management can be confusing

We offer several courses on risk management in compliance with ISO 14971.  Most of the courses can be taken online, or in-person. 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.

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


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.

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 10,000 people worldwide, on the best practices and knowledge on medical device safety risk management.

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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


Devakar Epari
Devakar EpariAssociate Professor in Biomedical Engineering at Queensland University of Technology, Australia, Co-inventor and developer of the Biphasic Plate
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“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.”
Mike Faltys
Mike FaltysChief Technology Officer, Phantom Neuro
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"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. "
Clifton Ericson
Clifton EricsonAuthor, Risk Management Expert
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" If you work in the medical device field, either in design or safety, this book is a definite required read."
Teun Hoevenaars
Teun HoevenaarsSystems Engineer, Vitestro, Netherlands
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Thank you for your insightful and clear session! It has caused me to reflect on some of our ways of working and triggered several constructive discussions. So many thanks once more. I will definitely be interested in your additional courses.
Benjamin Low
Benjamin LowSenior Quality Engineer, Vaxxas, Australia
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Many of the risk management courses I’ve done in the past have been a regurgitation and explanation of ISO14971 with a few examples thrown in. In contrast, the course delivered by Bijan at MedTech Safety provided a comprehensive insight into risk management – what it is, how it’s done well, practical tips for success, and hands on examples of working through some of the more complex aspects of the discipline. We all walked away with a good understanding of risk management and how we can apply it.