The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
Should we treat it as a hazard, a hazardous situation or a harm?
A diagnostic device gives a false or invalid result causing a delay in diagnosis and therapy. The software controlling a medical...
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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