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

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 wrote: > > Anyone who can give m

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

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 m

[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 Am