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LTR Weekly Digest #38 - 25th May, 2024

Catch up on this week's articles - 5 surprising facts about AI/ML devices, a bonus free article, Fidelis lead recall analysis and a quick tip to consider duration of hazard exposure in risk analysis.

Dear colleagues, hello! 👋

A special welcome to the 30 new members who joined our Let’s Talk Risk! community last 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.


Bonus free article:

ISO 14971 fundamentals: understanding sequence of events

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September 27, 2023
ISO 14971 fundamentals: understanding sequence of events

A common challenge for risk practitioners in the medical device industry during risk analysis is to identify foreseeable sequences and combinations of events leading to a hazardous situation as required by ISO 14971:2019: For each identified hazard, the manufacturer shall consider the reasonably foreseeable sequences or combinations of events that can re…


Feature article:


Other articles:


Announcements

LTR weekly conversation on LinkedIn: Fostering collaboration between QA/RA and Engineering functions

Join me next Friday, May 31, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest is Christine Zomorodian, who will share best practices for fostering collaboration between QA/RA and Engineering functions.

Join the Conversation


Weekly Knowledge Challenge

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

The correct answer to the question, “Which of the following elements are expected to be included in a policy to establish the criteria for risk acceptability” is All of the above.

Here is this weeks’ knowledge challenge #35

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