I am writing a series of articles for Compliance Engineering on the approval of medical devices and need information. I have what I need on UL 544, IEC 601, etc and on EMC issues. What I am looking for is information, including war stories, on FDA approvals and proving safety and effectiveness in the context of a 510k or PMA process.
I am also looking for information on approvals in Europe. I have what I need on the MDD, but would like sources for guidance documents, lists of notified bodies, information on sectoral or approval groups and publications in Europe dealing with the subject. Information on current process (i.e pre-MDD) is also appreciated. Finally the identity of newsgroups and mailing lists on the subject is also appreciated. Glen Dash
