LTR Weekly Digest #11 - 4th November, 2023
Catch up on this week's articles: a practical approach for analyzing benefit-risk, 25 LTR conversations and a quick tip about building a strong link between clinical evaluation and risk management.
Dear colleagues, hello! 👋
➡️Evaluation of the overall residual risk of a medical device in the context of the benefits of its intended use is a requirement of ISO 14971 in Clause 8. This exercise proves to be challenging in practice because benefit-risk analysis involves a lot of clinical judgment. As part of our monthly webinar series, I discussed this topic in detail and shared a few practical tips using 3 case study examples of recently approved/cleared medical devices. Full recording of the webinar is available to premium subscribers in this article below.
➡️Hard to believe, but we have just completed 25 Let’s Talk Risk! conversations on LinkedIn! These weekly conversations are designed to engage and inspire. Each week, we meet via LinkedIn live audio to talk about risk-related topics in a casual, informal way. Check out recordings of our previous conversations in this article below and join us next time.
➡️Clinical evaluation of medical devices is now more important than ever, especially because of a strong emphasis in EU-MDR, the revised medical device regulation in the European Union. Here is a quick tip to build a strong link between clinical evaluation and risk management.
Upcoming Events
LTR monthly webinar series: why FMEA alone is not sufficient for risk analysis.
Join me in this month’s webinar, where I will review the ISO 14971 requirement for risk analysis, identify some of the limitations of using an FMEA, and share a practical tip to link an FMEA with Hazard Analysis for a more complete analysis.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on November 14, 2023 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.
LTR weekly conversations on LinkedIn: how to be inspection-ready using a risk-based approach.
Join me next Friday, November 10, 2023 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest next week is Vincent F. Cafiso, who will share insights on inspection readiness based on many years of experience both at the FDA and the medical device industry. Click below to learn more and add it to your calendar!
Weekly Knowledge Challenge #9
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The best way to characterize the situation, where an in-vitro diagnostic (IVD) device yields an inaccurate result to the clinician resulting in wrong diagnosis, is to treat it as a hazardous situation (see Annex H in ISO/TR 24971:2020).
Here is this weeks’ knowledge challenge.
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