FDA Device GMP Guidance: Computerized Devices

FDA CDRH’s “APPLICATION OF THE MEDICAL DEVICE GMP TO COMPUTERIZED DEVICES ANDPROCESSES: MEDICAL DEVICE GMP GUIDANCE FOR FDA INVESTIGATORS” dated May 1, 1992. This document was developed as a guide to FDA inspectors in applying the 1976 Good Manufacturing practices to Computerized Medical Devices and to automated equipment and computer systems used in the manufacturing process. Although the GMP was revised and is now referred to as the Quality System Regulation FDA’s division of small Manufacturers Assistance chose to redistribute this document (actually an earlier revision of it) as relevant to the Quality System Regulation as an attachment and to their Quality System Regulation manual which was issued in December of 1996 shortly after the effective date of the Quality System Regulation.

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Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

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