The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Note: this article is a summary of the original article published on my Let's Talk Risk! newsletter. Read the full article here.
Summary
This case study provides an easy way to estimate...
A clear understanding of reasonably foreseeable sequence or combinations of events leading to hazardous situations is critical for identifying risks associated with the use of a medical device. In...
There is a lot of confusion in the medical device industry about the term hazardous situation. It is a common practice in the industry to equate failure modes to hazardous situations, but that is...
If you are using an FMEA to define sequence of events and hazardous situations relevant for your medical device, you are likely having a difficult time. Here is an easier, more direct way to meet...
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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