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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Why You Should Use Standard Codes for Adverse Events in Your Risk Files benefit-risk fda interactive q&a iso 14971 postmarket surveillance Feb 06, 2022

Global regulatory authorities require the use of standardized codes for reporting adverse events. Here are two reasons why you should also use standardized codes and terms in your risk...

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Coming Soon - ISO 14971:2019 Harmonization in the EU interactive q&a iso 14971 risk management Sep 27, 2021

According to the latest news, a final draft of the ZA and ZB annexes for harmonization of ISO 14971:2019 is currently going through the voting process

ISO 14971, the International Standard for...

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