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The ACHIEVE Blog

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

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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Risk Management Lessons
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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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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