April 2026 Newsletter – Better risk management for medical devices
How to start learning about medical device risk management?
I teamed up with a couple of new grads to put together this list of online resources to help newcomers to risk management. The material in this “starter kit” starts at a beginner level but also includes deeper dives into different aspects of risk management. If you know anyone who wants to start learning about risk management or others who want to learn more, please pass this along to them. And if you can recommend additional resources that should be included in the starter kit, please let me know and I’ll add them.
Common risk management mistakes and misconceptions
Here’s a list of the most common risk management mistakes and misconceptions I’ve encountered. Have you seen any of these at your company? Hopefully, greater awareness of these will help product teams and companies make better, safer medical devices.
Good risk management isn’t ad hoc
Starting with a clinically reviewed master list of hazardous situations, harms, and severities is a key way to improve risk management for a new medical device. After the list is completed, reuse it everywhere to speed up and standardize risk assessments and related activities.
Are there hidden problems in your Risk Management File?
Instead of waiting to find out during an FDA submission or from an auditor, contact us for a quick, independent review of your risk documentation at a time of your choosing. Our Risk Management Spotlight service shines a light on risk management issues and provides practical recommendations for addressing them.
Upcoming Events
Device Talks Boston – Boston – May 27-28, 2026
A two-day conference focused on medical industry product development.
https://boston.devicetalks.com
International MedTech Safety Conference (IMSC26) – Boston – June 2-5, 2026
This conference is dedicated to medical device risk management with presentations and workshops from a variety of experts in the field. The conference supports online attendees for those who can’t attend in person.
Validated AI Conference – Recorded
There were some great discussions at the Validated AI Conference here in Boston on April 9th. I learned a lot about how regulated companies in medtech and biotech are figuring how best to manage AI in their products and operations. If you missed it, recordings are available by request on the Ketryx website: