LTR Weekly Digest #19 - 13th January, 2024

Catch up on last week's articles: Getting ready for QMSR, a conversation about improving collaboration and a quick tip about setting up a robust post-market surveillance process.

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Dear colleagues, hello! 👋

A special welcome to 75+ new members who have joined our Let’s Talk Risk! community this month! 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

➡️The upcoming Quality Management System Regulation (QMSR) is expected to place a heavy emphasis on risk as the FDA seeks to align the current regulation with global standards. This premium article offers a review of risk-based requirements in ISO 13485 and guidance for implementation.

➡️In this Let’s Talk Risk! conversation, Bijan Elahi shares tips for creating and nurturing an environment of collaboration in risk management.

➡️A common challenge in risk management is to fully understand and control risks due to reasonably foreseeable misuse. This is why you need a robust post-market surveillance process so you can take timely action to ensure your devices continue to remain safe and effective.

Upcoming events

LTR weekly conversation on LinkedIn: Connecting risk management and design controls to accelerate product innovation

Join me next Friday, January 19, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Chuck Ventura, who will share insights on how we can connect risk management and design controls to accelerate medical device innovation.

LTR conversation with Chuck Ventura

LTR monthly webinar series: Getting ready for QMSR

A quick reminder to join me in this month’s webinar, where I will review some of the risk-based requirements of ISO 13485:2016 that may be relevant for your QMS as you prepare for the upcoming Quality Management System Regulation (QMSR) expected to be finalized soon.

If you are a paid subscriber, an email has been sent to you with a link to register for this month’s webinar on January 16, 2023 at 11:00 AM EST. You don’t need to pay extra. Please check your spam or promotions folder if you cannot find it in your inbox.

If you a free subscriber, you can upgrade your subscription to attend this webinar, or with a one time payment of only $25. Click the link below to complete your 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 January 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, “What is your best estimate of the number of times the terms “risk” or “risks” appear in ISO 13485:2016?”, is between 30-40 times.

Here is this weeks’ knowledge challenge #15


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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!