COURSE / module Detail
Software Development for Medical Device Manufacturers
Description: Course 1 provides definitions, regulatory roadmap, device classes and a discussion of regulations, guidance documents. Course 2 discusses standards, software FDA regulates, overview of quality management system and provides insight into software defects. Courses 3 and 4 discuss the FDA Quality System Regulation (QSR) Design Controls from a software perspective. Requirements from IEC 62304 are also included in this discussion.