Dear colleagues, hello! 👋
A special welcome to 180+ new members who have joined our Let’s Talk Risk! community in the month of January! 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.
Announcements
LTR weekly conversation on LinkedIn: Tips for post-market surveillance
Join me next Friday, February 9, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Taylor Dieringer who will share tips for effectively collecting and reviewing post-market information to inform timely action.
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 soon 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.
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!
Weekly Knowledge Challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer for the question, “Which of the following processes of a QMS is explicitly required to document risk management activities according to ISO 13485:2016”, is Product Realization (Clause 7.1). Only 25% have answered it correctly so far.
Here is this weeks’ knowledge challenge #19
1-Question Feedback Survey
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LTR Weekly Digest #22 - 3rd February, 2024