Device risk concept: A concrete method of risk assessment for quality system software.

摘要

The Food and Drug Administration (FDA) regulates medical device manufacturers through the Quality System Regulation (21CFR820) and Electronic Records and Electronic Signatures (21CFR11). These regulations require that automated processes be validated for their intended use. The FDA, however, fails to provide regulatory guidelines regarding risk management for meeting these requirements, although they suggest the level of validation be commensurate with risk. This research examines the international standard, ISO 14971, used for risk management of medical devices, as a reference for risk evaluation when automating processes required for compliance with the QSR. Contemporary methods for assessing risk associated with automated quality system software have focused on the size and complexity of the software. This research proposes a new model called, Device Risk Concept, to perform the risk assessment. The risk assessment is based on both the device class and the process being automated.