Dear colleagues, hello! 👋
Happy New Year to you!
I am super excited to continue our work here on Let’s Talk Risk! (LTR) with the single-minded focus on helping all of us achieve success in risk management. Our industry is going through a major transition, with rapidly advancing technology and evolving regulatory landscape across the globe. That is why it is even more important now to support the risk practitioner community through LTR.
In 2024, we will focus on the following themes:
Getting ready for the QMSR transition in the US
Tracking AI/ML applications in MedTech
Navigating the evolving regulatory environment, especially for SaMD and Cybersecurity
Growing the LTR community
It’s going to be a great year! Best wishes to all of you in your work and I look forward to continuing our risk management journey together!
Here are links to the articles published last week on LTR
➡️Here is an update on FDA device approvals, 510ks, De Novos, recalls and warning letters issued during the month of November 2023. This is part of our monthly Medical Device News Update series.
➡️What does it take to be “inspection ready” at all times?
“Inspection readiness is a frame of mind, a daily practice, not a destination or a project deliverable”, says Vincent F. Cafiso in this Let’s Talk Risk! conversation.
➡️Generally speaking, design and development of medical devices is primarily driven by engineering considerations focused on desired functionality. Although, early clinical input is highly desired, direct access to physician’s and other users of a device in the clinical setting is not available to the design team.
This quick tip reminds us that understanding the full clinical context of use and physician’s view is essential for designing safe and effective devices.
Upcoming events
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, you will receive an email 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.
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 January 2024. Watch a course introduction video and check out testimonials from past attendees!
LTR weekly conversation on LinkedIn: Listening session for feedback and networking
Join me next Friday, January 12, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. This will be a general networking and feedback session.
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 best represents the full scope of the term risk applicable to a medical device in the context of ISO 13485:2016”, is “Safety + Performance + Regulatory Requirements”. Only 50% of the respondents got it right!
Here is this weeks’ knowledge challenge #14
1-Question Feedback Survey
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