The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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,...
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...
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...
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...
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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