Service

MT Promedt Consulting GmbH

Altenhofstr. 80 , 66386 St. Ingbert
Germany

Telephone +49 6894 581020
Fax +49 6894 581021
info@mt-procons.com

This company is co-exhibitor of
saarland.innovation&standort e.V.

Trade fair hall

  • Hall 7a / B09
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 7a): stand B09

Fairground map

MEDICA 2016 fairground map: Hall 7a

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses

Reports and analyses

  • 07  Medical Services and Publications
  • 07.01  Reports and analyses
  • 07.01.03  Evaluations

Evaluations

  • 07  Medical Services and Publications
  • 07.08  Logistic services

Logistic services

  • 07  Medical Services and Publications
  • 07.08  Logistic services
  • 07.08.06  Consulting for health organisations
  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.01  Biocompatibility testings

Biocompatibility testings

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Consulting for health organisations

European Authorized Representative services for medical devices and in vitro diagnostics

The regulations of the EU medical device directive 93/42/EEC (MDD), in vitro diagnostic directive 98/79/EC (IVDD), and the active implantable medical device directive 90/385/EEC (AIMDD) require a manufacturer located outside the European Economic Area (EEA) to designate a European Authorized Representative as a liaison to the European competent authorities. MT Promedt Consulting provides qualified and professional authorized representative services as required by the MEDDEV 2.5/10. Our services will support your company to comply with the European regulations and will open you the gate to the medical device market. MT Promedt Consulting European authorized service include:

legal interface
/ product notification to the German competent authorities
/ identification of requirements for and performance of national notifications
/ storage of technical product files
/ identification of language requirements
/ notification of clinical investigations and performance evaluations
/ interaction with EU competent authorities
/ authorized European address
/ free sales certificate services

product safety related activities
/ implementation of a medical device vigilance system
/ medical device incident and field safety corrective action (e.g. recalls) reporting system
/ liaison between manufacturer, distributors and European authorities

additional services
/ documentation review
/ advice on labeling materials
/ translation services

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About us

Company details

MT Promedt Consulting is a German based consultancy that works as an Authorized European Representative for non-European medical device and in vitro diagnostic manufacturers, serving as their legal address in EU member states according to the Medical Device Directive 93/42 EEC and In vitro Diagnostics Directive 98/79/EC. Our services are • Product notification at Competent Authorities in all European Countries • Regulatory concepts for CE marking • Preparation of Technical Product Files for Medical Devices and In vitro Diagnostics • Validation and Compliance Services • Quality Assurance Services: Development and Installation of quality management systems according to ISO 9000/ ISO 13485 • Planning and accomplishment of clinical trials in Europe

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Company data

Number of employees

1-19

Foundation

1995

Area of business
  • Electromedical equipment / Medical Technology
  • Medical Services and Publications