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The ACHIEVE Blog

Insights on risk management topics and tips and techniques for implementation.

 
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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Evaluating Benefit-Risk of Medical Devices benefit-risk fda medical device risk management Sep 15, 2021

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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Naveen Agarwal, Ph.D.

Hello and welcome to the ACHIEVE blog! Here, you will find insightful articles about risk management topics and common questions, as well as tips and techniques for implementation.

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