Zdrowie i gospodarka · 11/01/2002
Medical Devices: General Principles of Software Validation; Final Guidance for Industry and FDA Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "General Principles of Software Validation." This document provides guidance to medical device manufacturers and FDA staff concerning requirements for validating software used within medical devices, in device production, or in implementing the manufacturer's quality system.