Great regulatory work
starts with knowledge and passion …
MT Promedt Consulting GmbH is an EN ISO 13485:2016 certified regulatory consultancy based in Germany providing analytical and strategic services to the international healthcare market (medical devices, in vitro diagnostics, pharmaceutical and biotechnical industry).
The company supports manufacturers worldwide in the medical device approval and clearance process, international product registration and in the development of quality management systems. MT Promedt Consulting provides services as European Authorised Representative (EAR) for non-European medical device manufacturers according to the European Medical Device Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746.
Founded in 1995, the company is centrally located in Europe with a German office in St. Ingbert/Saarland and is represented in the USA with an office in Salt Lake City, Utah, USA.
Starting January 1, 2021, the company provides the services as UK Responsible Person via our subsidiary MT Promedt Consulting Ltd located in Oxford.
We offer
Tradeshows
Discover top-tier regulatory strategy consulting with MT Promedt Consulting. We assist manufacturers of medical devices and in-vitro diagnostics in complying with MDR and IVDR regulations. With our integrated solution for Authorised Representative services in the EU (EAR), UK (UK RP) and Switzerland (CH-REP), we facilitate your market access.
Visit our booth to learn more about our customised solutions and how we can help you conquer the European market.
ADLM 2024 | Chicago
July 30 – August 1
Booth 4447
McCormick Place Convention Center, Chicago IL
Medical Fair Asia 2024 | Singapore
September 11 – September 13
Booth 2S20
Marina Bay Sands, Singapore
Medica 2024 | Düsseldorf
Global Network
By accessing a global network of subsidiaries and partners in Australia, Brazil, Israel, Japan, Korea, Saudi Arabia, Singapore and the USA, MT Promedt Consulting provides in-depth knowledge across the lifecycle in medical technology from product development to the post-market period.
