LTR Weekly Digest #25 - 24th February, 2024

Catch up on this week's articles: LTR podcast about MDSAP and QMSR readiness, a new way to understand hazards, and a quick tip for growing your regulatory career.

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Dear colleagues, hello! 👋

A special welcome to 120 new members who have joined our Let’s Talk Risk! community so far in February! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section.

A new episode of the monthly LTR podcast now available!

➡️LTR podcast is a new monthly feature on Let’s Talk Risk!. Each month, we sit down with an industry leader to gain deeper, more actionable insights.

This month, we talk with industry veteran Rick Rios about the process-based auditing approach in Medical Device Single Audit Program (MDSAP) and how it could help prepare medical device manufacturers to comply with FDA’s Quality Management System Regulation (QMSR). Paid subscribers have fee access to the full podcast. Others can get full access by upgrading their subscription here.

Here are links to other articles published this week.


LTR weekly conversation on LinkedIn: Best practices for product success in a startup environment

Join me next Friday, March 1, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Devon Campbell, who will share tips for product success in a startup environment.

Join the Conversation!

Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!

Save your spot here to join the next cohort of the LIVE ISO 14971 certification training course starting in March 2024. Watch a course introduction video and check out testimonials from past attendees!

Pre-register now

Weekly Knowledge Challenge

I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:

The correct answer for the question, “The final rule on the Quality Management System Regulation (QMSR) from the FDA uses the same definition for "labeling" as in ISO 13485:2016.” is False.

Here is this weeks’ knowledge challenge #22


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