Company

MT Promedt Consulting GmbH is a Germany-based regulatory consultancy operating in the international health care market (Medical Device, In-vitro Diagnostics, Pharmaceutical and Biotechnology Industry). Founded in 1995, the company operates two German offices in St.Ingbert / Saarland and Tornesch / Schleswig-Holstein and a US office in Salt Lake City/Utah.

Furthermore, by accessing a global network of subsidiaries and partners in USA, Turkey, India, Singapore, Korea, and Argentina, MT Promedt Consulting offers a broad expertise and in-depth knowledge in all lifecycle sequences of healthcare products. We provide comprehensive information and help you acting in every development stage – we support business foundations for start-ups as well as guiding already well established health care companies through the regulatory maze in Europe. We help on realizing your strategic goals while obtaining new product approvals.

Furthermore we act as European Authorized Representative for our international clients according to the European Medical Device directives (MDD 93/42/EEC /revision 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC and In vitro Diagnostic Directive 98/79/EC).

In the area of clinical trials for medicinal products we act as the Legal Representative according to the Clinical Trial Directive (2001/20/EC).

Benefitting of years of experience in the fields of production, Quality Assurance and Regulatory Affairs of medical devices and pharmaceuticals, MT Promedt Consulting offers full service packages to you in order to speed up the process from product development to market clearance.