MT Promedt Consulting GmbH

Medical technology is a strictly regulated industry with a multitude of regulations and certification requirements. Since 1995 MT Promedt Consulting GmbH, located in St. Ingbert, Germany, has been providing support for medicical device- and IVD manufactures with CE certification and international registrations. The aim is to provide comprehensive consulting services to comply with the complex requirements of the medical device regulations and therefore a fast and cost-efficient access to international markets.

The complete service for CE certification ranges from the product-related regulatory strategy to the preparation of all documentation to prove conformity with the requirements of European regulations.

The company supports the establishment of modern company-specific quality management systems according to EN ISO 13485:2016 and accompanies the corresponding audits.

EN ISO 13485:2016 certified, MT Promedt Consulting GmbH also 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.

Since January 1, 2021, the company also offers the services as UK Responsible Person (UKRP) via our subsidiary MT Promedt Consulting Ltd located in Oxford.

Through a wide network of international cooperation partners, MT Promedt Consulting offers regulatory support to facilitate your market entry strategies in international markets. This includes also the services as in-country representatives as well as independent local license holders. We have partners in Asia, Australia, Brazil, Canada, China, Israel, Japan, Korea, Singapore, Saudi Arabia, Switzerland and the US.