Medical Device EMC Testing Services
Service Detail from F2 Labs
F2 Labs can assist you in determining what EMC and Electrical Safety standards and collateral standards are required for certifying your product so you can sell your medical device to global markets. Our experts are qualified to assist you in EMC testing a variety of medical devices, from highly advanced robotic surgical systems, basic over-the-counter devices, and everything in between. Backed by more than 30 years of experience, F2 Labs can provide you with the necessary medical device testing and certification to get your product in the hands of doctors and patients on a timely schedule.
We can provide you with the test reports that are required to submit your FDA 510K to the FDA in order to obtain FDA Medical Device Approval, for inclusion in your CE Technical File for Europe, the U.S. (NRTL), and Canadian (SCC) certification mark for medical devices, and for submittal to the Australian, Brazilian Authorities, and other international submittals.