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Medical device certification services

TUV USA provides comprehensive certification services for medical device manufacturers, including ISO 13485, EU MDR, and MDSAP, to support global market access.

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Trusted and reliable expertise in the medical device industry

Medical device technologies are evolving rapidly and so are regulatory requirements. TUV USA supports manufacturers, suppliers, and operators with ISO 13485 certification, EU MDR compliance, and MDSAP audits.

As part of the TÜV NORD GROUP, we deliver globally recognized certification services that help ensure compliance, enhance product safety, and enable efficient access to international markets.

With experienced auditors and a structured certification approach, we support you at every stage. 

TUV USA MDR & IVDR Booklets

MDR Booklet


This booklet offers a full overview of the EU Medical Device Regulation (MDR) and includes the latest M5 amendment.

IVDR Booklet


This booklet offers a full overview of the In Vitro Diagnostic Regulation (IVDR), including the latest amendments and updates.