Hi folks,
Thank you for all input. The scope will cover Safety, EMC, SW, etc … almost everything :-/ I’ll start looking into the IEC60601 series and FDA. Thanks again. Best regards Amund Fra: Jon Griver [mailto:jgri...@601help.com] Sendt: 12. juni 2015 07:44 Til: EMC-PSTC@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 of biocompatibility, software validation, risk management, sterilization validation (if there are sterile parts of the equipment), bench (functional) testing, etc., as well as clinical evaluation. For safety, the standard is IEC 60601-1, for EMC IEC 60601-1-2. Also particular standards, such as those mentioned by Brodie, may be applicable in addition to (not instead of) IEC 60601-1. The good news is that if the product has EU MDD (CE) approval, it probably complies with and has documentation to show compliance with the FDA requirements. The only area where there will be significant differences from the MDD requirements is for clinical evaluation, where the FDA is likely to have more stringent requirements for the proof of clinical efficacy. You will find all the requirements on the FDA’s site. I would start here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm Regards, Jon Griver http://www.601help.com 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 <mailto: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 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 <mailto:am...@westin-emission.no> > wrote: 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. 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