The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
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...
When making decisions about investigating customer complaints using severity of harm, make sure the severity levels are correctly and consistently applied.
In a recent warning letter, the FDA cited...
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...
Evaluating benefit-risk of a medical device is no easy task because it involves making a decision about their safety and effectiveness with very limited information.
There is no doubt that...
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