LTR Weekly Digest #24 - 17th February, 2024

Dear colleagues, hello! 👋

A special welcome to 80+ 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.

Here are links to other articles published this week.

AMA #1: Security risk assessment and vulnerability monitoring

LTR 40: A guest podcast with NAMSA - Part 1

Quick Tip: Integrate clinical evaluation activities in your product development plan.

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Announcements

LTR weekly conversation on LinkedIn: Best practices for designing clinical studies

Join me next Friday, February 23, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Dr. Emanuel Tkach, MD, who will share tips for clinical studies based on his experience both as a clinician and a researcher.

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LTR monthly webinar series: Benefit-risk evaluation of an AI/ML enabled device using FDA guidance

Final reminder to register for the monthly LTR webinar next week.

If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on February 20, 2024 at 11:00 AM EST. You don’t need to pay extra.

If not, you can still attend this webinar with a one time payment of only $25. Click the link below to make a payment and secure your spot. Once you complete the payment, you will receive the registration link by email.

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Special offer - On-demand ISO 14971 certification course

Looking to boost your credentials in medical device risk management?

Get certified now with this fully on-demand ISO 14971 certification course PLUS enjoy 6 months of complimentary premium access to the Let’s Talk Risk! website.

Watch a course introduction video and check out testimonials from past attendees!

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Weekly Knowledge Challenge

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

The correct answer for the question, “What is the main reason FDA is amending the device current good manufacturing practice (CGMP) requirements in 21 CFR 820 to the Quality Management System Requirements (QMSR)?”, is to harmonize/align with ISO 13485. 80% of the respondents have answered it correctly so far.

Here is this weeks’ knowledge challenge #21

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1-Question Feedback Survey

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