Medical Supplies

Altenhofstraße 80
66386 St. Ingbert
Germany

Phone: (+49-6894)581020
Fax: (+49-6894)581021
http://www.mt-procons.com
info@mt-procons.com

Company Contacts
Department/ Name Address

Regulatory Affairs / EAR Services MT Promedt Consulting GmbH, Altenhofstr. 80, 66386 St. Ingbert, Germany
info@mt-procons.com

Company Figures
Number of employees 1-19
Sales volume < 1 Mio US $
Export content > 75%
Year of foundation 1994
Area of business Electronical Equipment / Medical Technology

Services and Publications

Language: German Language: English Company Profile

Your Gateway to the European IVD and Medical Device Market
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

Product Information
10.01 Reports and analyses
Consulting Services for Regulatory Affairs, CE-marking, EAR 06.09.2007

MT Promedt Consulting is a consulting company who provides services in regard to regulatory affairs, CE-marking and quality management systems for medical devices and IVD manufacturers.
For Non-European manufacturer, we are an independent European Authorized Representative as required by the European IVD Directive 98/79/EC.
Via our cooperation partners we also provide services and support concerning research, performance evaluation and marketing.