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The ACHIEVE Blog

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

 
Webinar - 7 essential elements of a risk management plan iso 14971 compliance risk management plan Oct 11, 2023

Note: this article presents an excerpt of a webinar presented to subscribers of the Let's Talk Risk! knowledge-letter. Watch the full webinar here and subscribe.

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Maximize the value of your risk management file as a communication tool best practices effective communication helpful tips iso 14971 compliance risk management file Feb 27, 2023

As a medical device manufacturer, you are required to establish and maintain a risk management file for ISO 14971 compliance. But did you know that you can maximize the value of your risk...

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Risk management file structure
Risk management file structure made easy for ISO 14971 compliance audit preparation iso 1491 training iso 14971 compliance risk management tools Jan 23, 2023

ISO 14971 requires manufacturers to establish and maintain a risk management file for their medical devices. A risk management file (RMF) is an essential part of the risk management system, but it...

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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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