The ACHIEVE Blog

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

 
Confused about defining a hazardous situation? You are not alone! fmea hazard hazard analyis hazardous situation iso 14971 Jan 30, 2023

There is a lot of confusion in the medical device industry about the term hazardous situation. It is a common practice in the industry to equate failure modes to hazardous situations, but that is...

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Understanding the term "Hazard" fmea hazard hazard analysis iso 14971 risk analysis Jan 14, 2023

At first glance, the term hazard appears quite intuitive to understand. According to the dictionary, it is the source of danger. But it is not so easy to precisely define it when doing risk...

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