Dear colleagues, hello! 👋
A special welcome to 40 new members who have joined our Let’s Talk Risk! community this 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.
Check out these recent articles published last week on LTR
➡️Benefit-risk evaluation of a medical device proves to be quite challenging in practice. This is because there is no cookie-cutter formula to quantify the relative strength of benefits against known or potential risks. It also involves a lot of judgment based on the totality of evidence and clinical experience.
In this premium article, we follow the method outlined in a FDA guidance document to “reverse engineer” a benefit-risk determination worksheet for an AI-enabled device. This article is free for paid subscribers. Others can get full access by upgrading their subscription here.
➡️FDA accepts the use of objectively measured quality-of-life benefits in the overall benefit-risk determination of a medical device. In this Let’s Talk Risk! conversation, Ronald Baumans discusses why it is important to also consider quality-of-life benefits in the overall benefit-risk evaluation.
➡️A common challenge when implementing a QMS in a startup is to balance the business needs with the extent of control required to meet regulatory expectations. Check out this quick tip about taking a risk-based approach in establishing a QMS for a startup.
Announcements
LTR weekly conversation on LinkedIn: How to boost your knowledge of Medical Software and AI
Join me next Friday, January 26, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Professor Xenophon Papademetris from the School of Medicine at Yale University. He has recently launched a certificate courses in Medical Software and AI. He will discuss challenges in learning about this rapidly growing area and opportunities available to aspiring industry professionals.
LTR is launching a monthly podcast series for paid subscribers!
Starting in January 2024, paid subscribers to LTR will be able to gain deeper insights from industry leaders on a variety of risk-related topics in an exclusive monthly podcast. These podcasts are different from our weekly LTR conversations on LinkedIn because they are designed to go deeper into a specific topic.
This month I sat down with Vincent Cafiso to talk about the upcoming QMSR, inspection readiness and career advice for QA/RA professionals. A recording of this podcast is coming soon!
Free subscribers can gain full access by upgrading here:
Pre-registration is now open for the next session of Live ISO 14971 training on ACHIEVE. Paid subscribers get 20% off regular price!
Registration in the January 2024 session is now closed.
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, “All individual residual risks must be reduced to an acceptable level for the overall residual risk to be considered acceptable”, is FALSE. Only 43% have answered it correctly so far.
Here is this weeks’ knowledge challenge #16
1-Question Feedback Survey
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