The ACHIEVE Blog

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

Case study - When Miscalculating Risk Leads to a Warning Letter risk analysis warning letter Mar 29, 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.

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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...

Risk Management Lessons from an FDA Warning Letter complaints handling fda harm hazardous situation risk analysis severity warning letter Jan 16, 2022

When making decisions about investigating customer complaints using severity of harm, make sure the severity levels are correctly and consistently applied.

In a recent warning letter, the FDA cited...

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