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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 MDD 93/42/EEC.

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 MDD). New applications for MDD are not being accepted at this time. We are in the process of getting our designation to the MDR (Regulation (EU) 2017/745).

Please see below for more information about these certifications.

We are looking forward for your inquiry

Bradley Chen

Vice President
Medical Products Division, Americas

347-592-9872

bchen@tuv-nord.com