A white paper at the link provided gives an overview of the status of European Union medical device software regulation and provides suggestions on software validation. Some of the suggestions are based on FDA guidance documents. CMD Swartikel This paper was provided by Poul Schmidt-Andersen of Copenhagen Medical Devices which is an affiliate of SoftwareCPR.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.