Radiometrics maintains contacts with the FDA Center for Device and Radiological heath to insure that both we and the FDA understand the unique requirements of your medical electronic device to insure a painless approval process.
- FDA 510k – EMC approval testing for Medical Devices
- PMA – EMC approval testing for Medical Devices
- ANSI C63.27 – Evaluation of Wireless Coexistence
- IEC60601-1-2 – International Medical Device EMC Testing
- EN 12184:2009 – Electrically Powered Wheelchairs, Scooters and Their Chargers
- ISO7176-21 – Electric Wheelchair EMC testing
- ANSI/RESNA EMC 041 Ver.1.5: 11/1/94 – Electric Wheelchair EMC testing
- ANSI/RESNA WC Vol.2-2009 Section 21 – Electric Wheelchair EMC testing
- ISO 14708-1:2014 – Implants for Surgery, General Requirements for Safety