The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
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...
You are developing a new implantable medical device to facilitate a less-invasive surgical procedure compared to your current legacy medical device. How do you analyze and document both...
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