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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.”)
Dick
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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