Altenhofstr. 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 1-9 Mio US $
Export content max. 50%
Year of foundation 1995
Area of business Electronical Equipment / Medical Technology
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