With TÜV Rheinland, you get integrated testing, auditing, and certification – covering major markets such as Europe, USA, China, Japan, Australia, Canada, and Brazil – from a single trusted source. This simplifies your approval process and keeps everything centralized.

By bundling conformity assessments with audits – such as combining IEC testing with regulatory reviews – you avoid redundant processes and accelerate your time to market, without compromising compliance or safety.

Our specialists operate on the ground in key markets and stay current with national regulations. Whether it's UKCA, NMPA, PMDA, or FDA requirements, you benefit from direct access to reliable, region-specific expertise.

Every test, review, and certification we conduct ultimately serves one goal: ensuring devices are safe to use and perform as intended. We test across safety domains – from electrical to chemical to cybersecurity – to help safeguard patients and users worldwide.

Our services are structured around regulatory workflows with clearly defined stages – ensuring regulatory compliance for medical devices without guesswork or uncertainty.

TÜV Rheinland is a Notified Body under MDR/IVDR, an NRTL for the U.S. and Canada (cTUVus), and an MDSAP audit organization. Our globally recognized status ensures your approvals are accepted by the relevant authorities.