MedTech Is Booming. Stay Compliant

Projected MedTech sales by 2030
Predicted annual growth rate for the global MedTech market
Countries TÜV Rheinland serves in MedTech testing & certification
Medical technology patent applications in Europe (2022)

Why Choose TÜV Rheinland?

Biotech researchers analyzing genomic data via AI-driven molecular sequencing in a smart lab, optimizing high-throughput drug discovery workflow.

  • Trusted for Quality and Safety

    Our independent certification shows that your IVDs meet the highest standards – building trust with regulators, healthcare buyers, and patients.

  • Clear Compliance, No Surprises

    As an IVDR Notified Body, we translate legal requirements into clear, actionable steps – so your team always knows what to do next.

  • Faster Timelines, Proven Results

    Efficient project setup, dedicated contacts, and fast lab turnaround keep your certification process on track – from IVDR to ISO 13485 and MDSAP.

  • Audit-Ready, All Year Round

    Our structured audits, risk analyses, and transparent reports help you stay inspection-ready and avoid delays.

  • Global Access, One Partner

    CE, UKCA, FDA, and more – access key markets through one global provider, saving time and reducing complexity.

  • 40+ Years of IVD Expertise

    Work with experienced teams and specialized labs for high-risk, companion, and software-based diagnostics.

Certipedia – TÜV Rheinland Database for all Tested and Certified Products, Services and Organizations.