MT Promedt Consulting GmbH
Booth number: HALL 6A -A8-33
www.mt-procons.com
About us
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.
Address
Ernst-Heckel-Str. 7
66386 St. Ingbert
Germany
Phone: +49 6894 581020
Contact person:
Clemens Mohr
Director European Regulatory Affairs
E-mail: ear@mt-procons.com
Phone: +49 6894 581020
Dr. rer. nat. Barbara Kathage
Specialist Quality Management & Regulatory Affairs
E-mail: kathage@mt-procons.com
Phone: +49 6894 581020
Products & Services
Our services:
- CE marking
- QM systems
- clinical research
- performance evaluation
- International product registration
- preparation of technical product files
- European Authorised Representation for non-European manufacturers of medical devices and in vitro diagnostics as required by the European regulations.
- UK Responsible Person via our subsidiary MT Promedt Consulting Ltd. located in Oxford