MT Promedt Consulting GmbH

Booth number 2L-01C

MT Promedt Consulting is an EN ISO 13485:2016 certified German regulatory consultancy acting as European Authorized Representative as required by the European regulations.

About us

MT Promedt Consulting is an EN ISO 13485:2016 certified regulatory consultancy based in Germany acting in the international healthcare market. We provide services regarding CE marking and QM systems for manufacturers of medical devices and IVDs. For non-European manufacturers, we act as independent European Authorized Representative (EAR) according to the MDR/IVDR. Since January 1, 2021, we provide services as UK Responsible Person via our subsidiary MT Promedt Consulting Ltd. located in Oxford.

MT Promedt Consulting GmbH
Ernst-Heckel-Str. 7
66386 St. Ingbert

Phone: +49 6894 581020

Products and Services

Our services: 

  • CE marking 
  • QM systems
  • clinical research
  • performance evaluation
  • International product registration 
  • preparation of technical product files 
  • trainings (inhouse/online)
  • European Authorized Representation for non-European manufacturers of medical devices and in vitro diagnostics as required by the European regulations
  • UK RP service for manufacturers located outside the UK via our UK office located in Oxford (MT Promedt Consulting Ltd.)

Click here if you notice an image that violates copyright or privacy rights.

Get in contact

We only use functionally necessary cookies and the web analysis tool Matomo in order to optimally design and continuously improve our website for you. By continuing to use our website, you agree to this. Further information and an objection possibility can be found here: Data protection