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GeneralI Principles of Software Validation
This is an FDA Draft document on software test and validation.
As of June 1, 1997, the medical device quality system regulation is effective, including requirements for implementing design controls.
Those design controls include requirements for validation of software used in medical devices.
Further, the quality system regulation continues the requirement that when software is used to automate...
preview:
http://www.fda.gov
date: 1/11/2002
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