The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Coming Soon - ISO 14971:2019 Harmonization in the EU
Sep 27, 2021
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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 Medical Devices
Sep 15, 2021
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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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