Re: Documenting "bugs" in Medical Devices

Subject: Re: Documenting "bugs" in Medical Devices
From: Dick Margulis <margulis -at- fiam -dot- net>
To: TECHWR-L <techwr-l -at- lists -dot- raycomm -dot- com>
Date: Thu, 28 Aug 2003 09:12:00 -0400

The specific FDA publication that addresses the bug issue is _General Principles of Software Validation; Final Guidance for Industry and FDA Staff,_ dated 11 January 2002. As the title implies, this is a final version of the guidance. (A “guidance” document issued by the FDA is taken seriously by the industry. “Should” is interpreted as “must.”)


Diane Evans wrote:

When dealing with medical devices, you are most likely concerned with FDA regulations, otherwise known as 21 CFR Part 11 and similar regulations.

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