MT Promedt Consulting GmbH

Endorse Company
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