LTR Weekly Digest #9 - 21st October, 2023
Catch up on this week's articles: practical tips for implementing a risk management policy, importance of early clinical input and tips for simplifying IVD risk management.
Dear colleagues, hello! 👋
➡️ISO 14971 requires the top management of medical device manufacturers to define and document a policy for establishing criteria for risk acceptability. Such a policy provides a framework for evaluating risks associated with a medical device. As part of the ISO 14971 fundamentals series, this week’s premium article helps you build a better understanding of requirements an offers a practical tip for effective implementation.
➡️There are many benefits to including appropriate clinical input early in your design and development process. Yet, this is a common gap in the medical device industry, where the design process is primarily driven by engineering considerations. Sara Vazda discusses how seeking early clinical input can help you achieve market success later in this week’s Let’s Talk Risk! conversation.
➡️Finally, here are a few quick tips for you to simplify your IVD risk management process.
Upcoming Events
Reminder: Attend this month’s webinar on Oct 24, 2023
A quick reminder to register for the October webinar where I will share a practical approach to analyze benefit-risk for a medical device.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on October 24, 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 now open in the next phase of LIVE ISO 14971 training
The current session of the LIVE ISO 14971 training is about half-way through! This is a specially designed training to help you master the requirements of ISO 14971, and get some hands-on experience by building a risk management file from scratch. Each week, we meet for a 2h live session for a total of 5 sessions for the whole training. This way, you don’t have to take too much time off from work and you can absorb the training material in bite-size pieces. Learn about this training here.
If you are interested, you can pre-register here for the session starting in November, 2023. Cost of the training is $899 USD. Paid subscribers on the annual plan get a 20% discount!.
Space is limited to only 15 attendees at one time. Pre-register here:
Weekly Knowledge Challenge #8
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The statement “According to ISO 14971, probability of occurrence of harm must be estimated using the P1, P2 approach described in Annex C, Figure C.1.” is FALSE.
Here is this weeks’ knowledge challenge.
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There is a good spread on the knowledge challenge. I did have to mull it over for a while. I ended up with the most popular, but can certainly see why the second most popular is indeed the second most popular!