Dear colleagues, hello! 👋
A special welcome to the 120+ new members who have joined our Let’s Talk Risk! community so far in April! 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 articles published this week.
LTR 47: Cloud computing in MedTech, evolving regulatory landscape and career tips with Randy Horton
Announcements
Exclusive new content for paid subscribers
Exciting news - LTR is adding a brand new section on QMSR compliance!
FDA has published the final rule on the Quality Management System Regulation (QMSR), the revised quality system regulation for medical devices. It is due to go into effect on 2nd February 2026.
To help you prepare, LTR is launching a new featured section that will cover QMSR compliance related topics from the risk management perspective. Here, you will find insightful articles about QMSR requirements, case studies, special webinars and podcasts.
This feature is an additional benefit for paid subscribers only.
Upgrade your subscription today and save 20% on the annual plan.
LTR monthly webinar series: Case study discussion and general Q&A
A quick reminder to join me in this month’s webinar, where I will review a case study based on a recent FDA warning letter citing issues with risk estimation. We will also have a general Q&A session on your risk management question.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on April 23, 2024 at 11:00 AM EST. You don’t need to pay extra.
If not, you can upgrade your subscription, or pay a one time payment of only $25 to attend this specific webinar. 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.
Weekly Knowledge Challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer for the question, “Your auditor insists that you must use an FMEA for risk assessment in order to comply with ISO 14971. Are they correct?” is No.
Here is this weeks’ knowledge challenge #30
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LTR Weekly Digest #33 - 20th April, 2024