LTR Weekly Digest #23 - 10th February, 2024

Catch up on this week's articles: Using standard terms in risk files, linking risk management with design controls, a quick tip for gaining commitment for risk management, plus an upcoming LTR webinar

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Dear colleagues, hello! 👋

A special welcome to 60+ 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.


LTR weekly conversation on LinkedIn: A risk-based approach to purchasing controls

Join me next Friday, February 16, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Kevin Posey, who will share tips for a risk-based approach to purchasing controls. This topic is going to be very important for compliance with the QMSR.

Join LTR Conversation

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

A quick reminder to join me in this month’s webinar, where I will review a step-by-step method for benefit-risk evaluation of an AI/ML based medical device using FDA guidance.

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.

Register now to attend (Only $25)

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 February 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, “How long is the transition period for device manufacturers to comply with the amended QSR (QMSR) according to the recently published final rule from the FDA?”, is 2 years. Only 67% have answered it correctly so far.

Here is this weeks’ knowledge challenge #20


1-Question Feedback Survey


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