[PSES] SV: [PSES] Medical Device approval for U.S. market

@LISTSERV.IEEE.ORG Emne: Re: [PSES] Medical Device approval for U.S. market Amund, It’s not clear whether you are referring just to the safety and EMC requirements, or all the medical device requirements. In addition to safety and EMC, you also have requirements in the areas

Re: [PSES] Medical Device approval for U.S. market

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

[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

Re: [PSES] Medical Device approval for U.S. market

The Medical Device Designer’s Guide to IEC 60601-1 From: Brodie [mailto:brodi...@gmail.com] Sent: Friday, June 12, 2015 6:49 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Medical Device approval for U.S. market I would recommend you look to the requirements in IEC 60601-1-12 for emergency

Re: [PSES] Medical Device approval for U.S. market

I would recommend you look to the requirements in IEC 60601-1-12 for emergency medical service equipment, as well as IEC 60601-1-11 for the equipment used in the home healthcare environment. Regards, Brodie Pedersen On Jun 11, 2015, at 8:30 AM, Amund Westin am...@westin-emission.no wrote: