LTR Weekly Digest #2 - 2nd September, 2023
Catch up on this week's articles: review of 5 FDA guidance documents, applying a system safety approach, and leveraging team diversity to boost competence in risk management.
Dear colleagues, hello! 👋
I received positive feedback from many of you about reducing newsletter delivery frequency to only once per week. As a result, I will be sending you a weekly digest with links to Let’s Talk Risk! (LTR) articles on Saturday of each week.
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Weekly knowledge challenge
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ISO 14971, the international standard for application of risk management is currently in its third revision, issued in 2019.
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Here are the articles published this week
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A quick summary of 5 recent FDA guidance documents - Aug 2023
The US FDA frequently issues guidance documents for the industry and its own staff to clarify expectations and approach to regulatory decision making. In theory, these guidance documents are not legally binding. However, it is smart to follow all applicable guidance documents if you want to do business with the FDA, and achieve a favorable outcome for your medical device!
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Quick Tip: Start with system safety requirements for your medical device
A common practice in the medical device industry is to apply a bottom-up approach to risk analysis using a failure modes and effects analysis (FMEA) technique. Although, an FMEA is a useful technique for identifying and controlling potential failure modes, it is not effective at understanding system level hazards that may actually lead to harm.
Team diversity helps boost competence in risk management
Note: this article highlights key insights gained from a conversation with Rene Drost as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below. If you enjoyed this conversation, consider subscribing to