FDA Guidance: Contents of Premarket Submissions for Software Contained in Medical Devices, 5/05
$0.00
May, 2005 CDRH published this guidance to industry regarding software used in medical devices and software at blood establishments.
This guidance contains sections on software documentation, risk assessment & management, software change management, software of unknown pedigree (SOUP), virus protection software, and interfaces, networking, and network infrastructure.
Issuing Body | FDA Guidance Documents |
---|