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 * Home
 * Services
   * european authorised representative
   * strategic regulatory consulting
   * quality management systems
   * international product registration
   * trainings
   * uk representative
 * Contact


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.


Download our company profile+


WE OFFER


EUROPEAN AUTHORIZED REPRESENTATIVE


STRATEGIC REGULATORY CONSULTING


QUALITY SYSTEMS


INTERNATIONAL PRODUCT REGISTRATION


TRAININGS


UK REPRESENTATIVE


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

November 11 – November 14
Booth 7A B05

Messegelände 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.



Certificate EN ISO 13485:2016Zertifikat EN ISO 13485:2016

Ernst-Heckel-Straße 7
66386 St. Ingbert
Germany

phone | +49 6894 581020
fax | +49 6894 581021
info@mt-procons.com

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