NOTE: This is for historical reference as a final guidance was issued Sept 2017 and is posted separately. FDA issued a new draft guidance entitled “Design Considerations and Pre- market Submission Recommendations for Interoperable Medical Devices”. This guidance addresses medical devices that exchange information whether wired or wireless including through the internet. It includes unidirectional...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.