The ACHIEVE Blog

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

Why You Should Use Standard Codes for Adverse Events in Your Risk Files benefit-risk fda interactive q&a iso 14971 postmarket surveillance Feb 06, 2022

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...

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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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