TÜV Rheinland AG

TÜV Rheinland AG

German testing and certification organization providing medical device assessment, quality audits, and training services used to demonstrate regulatory and standards compliance.

Cologne, Germany
20000-23000 employees
Am Grauen Stein, 51105 Köln, Germany
Categories:
Medical Compliance, Regulation & Certification Services

Business Profile

Capabilities, markets, and positioning.

Business Model
service providercertification body
Value Chain Role
certification providertesting partner
Geographies Served
Worldwide
Key Capabilities
conformity-assessmentquality-management-auditsproduct-testingregulatory-trainingtechnical-documentation-review
Tags
certificationregulatorymedical-devicesquality

About

TÜV Rheinland AG is an independent testing and certification organization that supports product safety and compliance across regulated industries. In healthcare, it provides services used by medical device manufacturers and supply-chain partners to meet applicable regulatory and standards requirements.

Compliance services

Activities can include product testing coordination, quality system audits, and technical review aligned to relevant frameworks and standards. Training and advisory offerings help organizations build internal competence for documentation, risk management, and continuous compliance.

Market access support

Operating internationally, TÜV Rheinland works with manufacturers seeking access to multiple regions. Its assessment and certification services help demonstrate conformity, improve process discipline, and support traceability and oversight throughout device lifecycles.

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Last edited January 7, 2026Edited by @diego1