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.
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.
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 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 9,000 people worldwide, on the best practices and knowledge on medical device safety risk management.
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