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Medical Device Risk Management
Bijan Elahi
MSEE BS AeroE

Bijan Elahi is an award-winning Medical Device Risk Management Author, Professor, and Consultant. Through Bijan’s expertise you can empower your company and teams to master ISO 14971, reduce risks, and ensure patient safety. Register your interest today!
Transform Your Approach to Risk Management

GLOBAL EXPERTISE
Access over 30 years of industry experience.

PRACTICAL KNOWLEDGE
Implement real-world solutions for today’s challenges.

ISO 14971 MASTERY
Understand and apply ISO 14971 effectively.

COMPLIANCE SIMPLIFIED
Streamline compliance with global regulatory requirements.

RISK REDUCTION
Reduce risks and improve patient safety.

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Delivery Options that Align With Your Needs
- Tailored Content
Customise training to fit your team’s unique needs, ensuring relevant, practical solutions that align with your organization’s goals.
- Group Training
Ideal for teams of 10 or more, this customizable program is designed to address your organization’s specific challenges and goals.
- Consulting
Receive tailored guidance to optimize your risk management processes and achieve compliance excellence.
- In-person or Live-online
Options to suit your schedule — choose in-person sessions or interactive live-online training from anywhere in the world.
What Clients Say

“Thank you for the two days of FMEA and Risk training! The course material was excellent, the class style was engaging, and you are an insightful and great teacher. Our team, business, and devices will all benefit from this valuable experience.”
— Training Participant, MEDTRONIC, USA

“Bijan’s expertise is unsurpassed and he teaches in an easy-to-understand manner. He was very patient, inspiring, organized, passionate and open to suggestions. This is the most useful training I have taken in the PDEng.”
— Training Participant, Philips, Netherlands

“Thank you for the two days you’ve spent expanding our horizons on risk management. Your knowledge & patience made those days meaningful for all participants.”
— Training Participant, MEDTRONIC, Israel

Safety Risk Management for Medical Devices Book
4.3 out of 5 stars on Amazon Books.
Bijan Elahi’s Safety Risk Management for Medical Devices book is an essential guide to mastering ISO 14971 and achieving regulatory compliance. It provides practical strategies, expert insights, and real-world examples to help professionals identify, assess, and mitigate risks effectively.
“An excellent companion for the medical device developers and entrepreneurs. Elahi’s methods and resources enabled first-timers 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 (QUT), Co-inventor and developer of the Biphasic Plate
Register Your Interest
Take the first step toward safer, more reliable medical devices.