Medical Products Division

The Medical Products Division of TUV USA offers four different certifications to the medical devices community:

ISO 13485, MDSAP, EN ISO 13485, and Medical Device Regulation (EU) 2017/745. 

Two of the four are offered through TUV USA’s accreditation (ISO 13485, MDSAP) and two additional are offered using our sister company TNC’s accreditations (EN ISO 13485 and MDR). 

Please see below for more information about these certifications.