The draft of the US ONC proposed 2015 HealthIT ceritfication requirements rule is at the link provided. The final will be published March 30, 2015. This new version requires use of a quality system and states: “….QMS established by the federal government and SDOs include FDA’s quality system regulation in 21 CFR part 820, ISO...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.