The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
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...
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...
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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