One-Stop Global Market Access for Sustainable Devices
Integrated testing, auditing, and certification for international medical device approval – including CE, FDA, MDSAP, and sustainability standards – from a single trusted source.Efficiency That Saves Time & Resources
By combining regulatory and sustainability checks – from IEC 60601-1 and ISO 13485 to Product Carbon Footprint – we reduce redundancy, cost, and certification timelines.Local Experts and Accredited Labs Worldwide
A global testing network with accredited labs and in-country experts ensures consistent results, local regulatory support, and recognition of eco-design and certification marks.Patient Safety and Environmental Responsibility
Our impartial testing safeguards patients while advancing sustainability – from chemical and material compliance to energy efficiency and lifecycle-oriented services.Clarity in Complex Sustainability Requirements
Structured workflows cover documentation, carbon footprint transparency, and circular economy checks – providing clear steps across complex regulations.Trusted & Recognized Worldwide
As an MDR/IVDR Notified Body, a U.S. NRTL (cTUVus), and a MDSAP Auditing Organization, TÜV Rheinland provides globally recognized certifications and sustainability programs accepted by regulators and procurement bodies.
Certipedia – TÜV Rheinland Database for all Tested and Certified Products, Services and Organizations.
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