The FDA website(s) are rather unruly, but is good place to start. You will eventually have to start a dialog with an NRTL, so talk to a local lab that is also an NRTL/SCC that has experienced medical labs in North America. The U.S. FDA and Health Canada, depending on the equipment type, can be more onerous than stuff for the EU.
The FDA has issued guidance docs for portable equipment. Brian From: Amund Westin [mailto:am...@westin-emission.no] Sent: Thursday, June 11, 2015 6:31 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Medical Device approval for U.S. market Anyone who can give me a tip where to start looking for the requirements? Talking about portable medical equipment, and also for use in vehicles and aircrafts. CE Medical Device Directive approval (by a notified body) will be in place before the U.S. approval project starts. Regards Amund - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
