The first committee draft of the second edition of “IEC 62304 Medical device software life cycle processes” has been circulated internally for comment. Major changes include a revision of how software safety class is determined, which could reduce the tendency towards most software being Class C; clear requirements for legacy software that explain how conformance...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.