The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Weekly Live Series, Episode 3: Understanding Severity Levels
May 16, 2022
Continue Reading...
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
Jan 16, 2022
Continue Reading...
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...
LET'S TALK RISK! NEWSLETTER
Say yes to receiving a practical risk management tip each week!
You're safe with me. I'll never spam you or sell your contact info.