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LTR Weekly Digest #30 - 30th March, 2024

Catch up on this week's articles - bonus free podcast, monthly review of FDA actions, AI/ML devices and a quick tip about using a risk-based approach for SaMD.

Dear colleagues, hello! 👋

A special welcome to the 140+ new members who have joined our Let’s Talk Risk! community in the month of March! 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.


Free bonus LTR podcast

Now, all subscribers can watch the full recording of my podcast with Vincent Cafiso!

💓Love this content? Upgrade your subscription and start enjoying these in-depth conversations!


Here are links to articles published this week.


Announcements

LTR weekly conversation on LinkedIn: The power of communication and collaboration for QA/RA professionals

Join me next Friday, April 5, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Subhi Saadeh, who will share lessons learned from over 100 podcast conversations with QA/RA leaders.

Join the conversation


Ask a risk management question

Got a risk management question? Now you can submit your question and get answers through a new feature on Let’s Talk Risk!. If I pick your question for an AMA article, you will get free access to premium content for 30 days!

Ask a RM question!


Weekly Knowledge Challenge

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

The correct answer for the question, “Compliance to ISO 14971 is mandatory to comply with ISO 13485, the quality management system requirements standard for medical devices” is False.

Here is this weeks’ knowledge challenge #27

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