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
Upcoming Public Courses
No public courses are planned at this time.
If you would like to discuss a private, onsite course, please fill out the form below.
