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LTR Weekly Digest #21 - 27th January, 2024

Catch up on this week's articles: Recording of a webinar about QMSR, first episode of a new monthly podcast series and a quick tip about leveraging AI/ML to drive innovation in MedTech.

Dear colleagues, hello! 👋

A special welcome to 35 new members who have joined our Let’s Talk Risk! community this week! 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.

Great news! We are launching a new monthly podcast series on LTR.

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

We are kicking off this series with an insightful conversation with Vincent Cafiso about the upcoming QMSR, inspection readiness and career tips for QA/RA professionals. 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.


Announcements

LTR weekly conversation on LinkedIn: Patient perspective on medical devices.

Join me next Friday, February 2, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is David Sturgis who will share his experience with a medical device from a patient’s point of view.

LTR conversation on LinkedIn


Special training offer with 6-month complimentary LTR subscription

✅ Want to build mastery of medical device risk management at your own time, at your own pace, and at an affordable price?

➡️Then sign up for this fully on-demand ISO 14971 certification course. Same content as in my Live ISO 14971 training.

As a bonus, I am offering a 6-month complimentary premium subscription (a $120 value) to Let’s Talk Risk!

🚀Click below to register and get started today.

ISO 14971 Certification Course


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 upcoming QMSR will mandate compliance to requirements of ISO 14971 for risk management in QMS processes”, is FALSE. 83% have answered it incorrectly so far.

Here is this weeks’ knowledge challenge #17

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