The ACHIEVE Blog

Insights on risk management topics and tips and techniques for implementation.

Case study: using post-market data to evaluate changes in risk level hazardous situation postmarket surveillance probability risk analysis Sep 18, 2023

Note: this article is a summary of the original article published on my Let's Talk Risk! newsletter. Read the full article here.


Summary

This case study provides an easy way to estimate...

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Weekly Live Series, Episode 4: Challenges of Using P1, P2 Approach achievelivesessions probability risk analysis risk estimation risk level May 23, 2022

Although not a mandatory requirement of ISO 14971, it is a common practice in the medical device industry to use the P1, P2 approach for estimating the probability of harm (POH). In many cases,...

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