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.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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