The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Although not a mandatory requirement of ISO 14971, it is a common practice in the medical device industry to use the P1, P2 approach for estimating the probability of harm (POH). In many cases,...
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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