The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
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...
This week, we kicked off our Weekly Live Discussion Series! We talked about Hazard Analysis and why it becomes challenging if you try to combine it within a FMEA (Failure Mode Effects...
Should we treat it as a hazard, a hazardous situation or a harm?
A diagnostic device gives a false or invalid result causing a delay in diagnosis and therapy. The software controlling a medical...
You are developing a new implantable medical device to facilitate a less-invasive surgical procedure compared to your current legacy medical device. How do you analyze and document both...
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