A presentation of a proposal for EU software regulation at the ISPRA meeting on Medical Device Software May 13, 2003, is at the link provided. Some of the suggestions are based on FDA guidance documents. ISPRA Meeting on SW This presentation 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.