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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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Confusion about failure modes and hazardous situations
Use these 4 steps to define hazardous situations and foreseeable sequence of events failure mode fmea hazard analyis hazardous situation risk assessment risk management Feb 15, 2022

If you are using an FMEA to define sequence of events and hazardous situations relevant for your medical device, you are likely having a difficult time. Here is an easier, more direct way to meet...

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Naveen Agarwal, Ph.D.

Hello and welcome to the ACHIEVE blog! Here, you will find insightful articles about risk management topics and common questions, as well as tips and techniques for implementation.

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