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 the Let's Talk Risk! newsletter on Substack, a reader-supported publication. Read the full article here.
ISO 14971,...
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...
ISO 14971 requires identification and documentation of hazards and hazardous situations as part of risk analysis. If you are using an FMEA as the only way to document applicable hazards and...
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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