Testing and Certification Body for Medical Devices
The European Testing and Certification Body for Medical Devices (PMG) is part of the Institute of Health Care Engineering. With the affiliated Testing and Certification Body for Medical Devices (PMG), the University of Technology Graz is the only university in Europe having an European Notified Body (No. 0636) which is not only authorized to test medical devices, but also to issue certificates allowing products being placed on the entire European market.
Range of services offered to clients:
- EC type-examination (for medical devices of class IIb and III) combined with certification
- EC verification (outsourced manufacture-final-inspection or –testing of medical devices of class IM, IIa and IIb) combined with certification
- Type-testing according to the type-testing standards (e.g. EN 60601-1, EN 60950, EN 61010) combined with type-testig report
- Safety-related basic examination (for medical devices of class IIa and I)
- Safty-related testing (periodical testing of medical devices in use according to MPG and KAG)
- Certification of quality management systems of manufacturers according to EN ISO 13485 and/or EN ISO 9001
ATTENTION! The PMG is relocated to Stremayrgasse 16!