Summary

“This conference is really by the community and for the community - a place where people passionate about MedTech safety can come together to share ideas, learn, and make a difference.”

In this Let’s Talk Risk! conversation, host Dr. Naveen Agarwal welcomes back renowned safety risk management expert Bijan Elahi to discuss the upcoming International MedTech Safety Conference 2026 in Boston.

Bijan shares the inspiring story of how a grassroots effort among passionate professionals has grown into a global movement for advancing safety risk management in medical devices. From its beginnings at Medtronic headquarters to a sold-out conference in Amsterdam, this event has become a central hub for knowledge exchange between industry, academia, and regulators, including keynote participation from FDA CDRH Director Dr. Michelle Tarver.

Together, Naveen and Bijan explore emerging themes shaping MedTech risk management today - AI and machine learning, combination products, and proactive safety by design - and highlight the many ways professionals can get involved in shaping the future of safety science.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introduction and welcome01:40 Emerging themes in MedTech risk: AI and combination products03:30 Why Bijan created the MedTech Safety Conference05:00 From Medtronic to Amsterdam: a 400% growth story06:45 The 2026 theme: Proactive Safety by Design08:30 Academic and regulatory collaboration (Northeastern, MIT, FDA)10:00 QMSR and the growing role of risk-based assurance12:00 Conference structure: workshops, keynotes, collaboration day15:00 How to participate: speak, teach, or lead a discussion18:00 Abstract selection and deadlines21:00 New ISO documents on AI/ML and combination devices23:00 Early-bird registration and next steps25:00 Closing thoughts and key takeaways

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Suggested links:

Conference Website: Program, Abstract Submission, Early Bird Pricing.

LTR: Tips for Improving Collaboration in Risk Management.

ACHIEVE Workshop: Using ChatGPT to Analyze Recalls and Adverse Events.

Key Takeaways

* The MedTech Safety Conference 2026 will be held at Boston at Northeastern University, from June 2-5, 2026.

* The conference theme: “Proactive Safety - From Clinic to Home” emphasizes the focus on building safety into devices from concept.

* The event has grown 400% since its first year, proving global momentum.

* Dr. Michelle Tarver (FDA CDRH) is an invited speaker to deliver a keynote, highlighting the importance of safety in medical devices.

* New ISO guidance documents 24971-2 (AI/ML) and 24971-3 (Combination Devices) are expected to launch just before the event.

* The conference includes an expanded four-day program includes workshops, keynotes, and a “Day of Collaboration.”

* It brings together industry, academia, and regulators in one shared forum.

* AI and combination products are today’s top emerging risk themes.

* Abstracts open through Dec 31, 2025; early-bird registration at medsafety.net.

* This conference is a grassroots, non-commercial movement: by the community, for the community.

Keywords

MedTech Safety Conference 2026, Proactive Safety by Design, Risk Management, QMSR Readiness, AI/ML in Medical Devices, Combination Products, ISO 24971-2, ISO 24971-3, FDA CDRH, Medical Device Safety

About Bijan Elahi

Bijan Elahi is the founder of MedTech Safety and a globally recognized expert on safety risk management of medical devices. Bijan is a technical fellow, and an affiliate professor at Drexel University, USA. Bijan is also a lecturer at Eindhoven University of Technology in the Netherlands, where he teaches risk management to doctoral students in engineering. He 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 has trained over 10,000 people worldwide and his book Safety Risk Management of Medical Devices, now in its second edition, is a bestseller.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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