FDA Issues New Draft Guidance on Medical Device Quality System Software Assurance
21 CFR 820, the regulation that outlines the quality management system requirements for medical devices manufactured or distributed in the US, defines requirements for production and process controls in sec. 820.70 to ‘ensure that a device conforms to its specifications, with 820.70(i) listing the only requirements for software validation in automated processes, something that has […]
After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485
After four long years and constantly slipping timelines, the FDA is finally making good on efforts to harmonize its Quality System Regulation (QSR), defined in 21 CFR 820, with the international standard for medical device quality management systems, ISO 13485, with a proposed rule issued Tuesday, 2/22/2022, with the resulting regulation being dubbed the Quality […]