The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
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...
Evaluating benefit-risk of a medical device is no easy task because it involves making a decision about their safety and effectiveness with very limited information.
There is no doubt that...
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