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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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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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