The ACHIEVE Blog

Insights on risk management topics and tips and techniques for implementation.

ISO 14971 Fundamentals: Reasonably Foreseeable Misuse iso 14971 fundamentals reasonably foreseeable misuse Dec 06, 2023

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...

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There is more to hazard analysis than FMEA fmea hazard analysis iso 14971 fundamentals risk analysis Feb 21, 2023

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...

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Understanding reasonably foreseeable sequence of events for ISO 14971 risk analysis event tree analysis hazardous situation iso 14971 fundamentals risk analysis sequence of events Feb 13, 2023

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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