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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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Naveen Agarwal, Ph.D.

Hello and welcome to the ACHIEVE blog! Here, you will find insightful articles about risk management topics and common questions, as well as tips and techniques for implementation.

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