LTR Weekly Digest #7 - 7th October, 2023
Catch up on this week's articles: webinar on 2 ways to estimate probability of harm, insights for clinical evaluation and using FDA's 510k database for medtech intelligence.
Dear colleagues, hello! 👋
There is a lot of discussion about Clinical Evaluation, especially in Europe, where the new EU-MDR (and IVDR) has created a heavy emphasis on this topic. There are still a lot of unanswered questions, especially around the notion of clinical risk, and how to evaluate it throughout the device lifecycle. In this week’s Let’s Talk Risk! conversation, Sarah Panten discusses some of these challenges and emphasizes the key point that clinical evaluation is a lifecycle process, not a one-time activity.
Want to learn about two practical ways to estimate the probability of occurrence of harm? Watch the recording of the last month’s webinar here. Note that the full recording is available only to paid subscribers. You can get full access with a 7-day free trial, or upgrading your subscription here.
Finally, did you know that you can find a lot of useful information about medical devices on FDA’s 510k database? Even if you don’t intend to market your medical device in the United States, this information can help you study a similar device within the scope of your intended use, and plan your risk management and design validation activities. Learn about this powerful resource here.
Pre-registration now open in the next phase of LIVE ISO 14971 training
We kicked off the current session of LIVE ISO 14971 training this week! 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:
Ask a risk management question
Now you can ask a risk management question for quick answer and practical tips!
Weekly knowledge challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The statement “compliance to ISO 14971 is mandatory to comply with FDA’s Quality System Regulation” is FALSE.
Check out this week’s knowledge challenge question by scrolling down to the end.
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