The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Reasonably foreseeable misuse in the context of ISO 14971 is more than use-error.
Note: this article is a summary of the original article published on the Let's Talk Risk! newsletter. Read the...
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...
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