The ACHIEVE Blog

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

ISO 14971 Fundamentals: Characteristics related to safety best practices iso 14971 fundamentals postmarket surveillance safety Mar 12, 2024

Note: this article is a summary of the original article published on the Let's Talk Risk! newsletter on Substack, a reader-supported publication. Read the full article here.



 

ISO 14971,...

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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 6: Data Sources for Post-Market Surveillance achievelivesessions data postmarket surveillance Jun 22, 2022

Analysis of post-market data is critical to ensuring continued safety and effectiveness of our medical devices. It is also a requirement of ISO 14971:2019. A common practice in the medical device...

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Weekly Live Series, Episode 3: Understanding Severity Levels achievelivesessions postmarket surveillance risk estimation severity warning letter May 16, 2022

In this episode, we focus on some of the practical challenges in implementing a severity scale to analyze the risk of harm associated with medical devices. Industry practice is to use a 1-5 scale...

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Why You Should Use Standard Codes for Adverse Events in Your Risk Files benefit-risk fda interactive q&a iso 14971 postmarket surveillance Feb 06, 2022

Global regulatory authorities require the use of standardized codes for reporting adverse events. Here are two reasons why you should also use standardized codes and terms in your risk...

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