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European Medical Manufacturing Suppliers Directory Index
Medical Technology Promedt Consulting GmbH
Altenhofstrasse 80
St Ingbert, D-66386 Germany
Tel: +49 6894 581 020
Fax: +49 6894 581 021
E-mail: info@mt-procons.com
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Description:
Serves as a European authorised representative for non-European medical device and IVD manufacturers. Services offered include product notification, labelling assistance, incident report organisation and interaction with competent authorities. Additional services are provided for regulatory affairs, quality assurance, CE marking strategies and preparation of technical product documentation, including sterilisation validation and product testing. New services involving clinical studies in Europe include study design, protocol development, monitoring, and reporting, performed in cooperation with clinical partners. All services are in compliance with EC regulations.
Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:
- Consultants: Auditing/Inspections (70 companies)
- Consultants: Conformity assessment (47 companies)
- Consultants: Product certification (46 companies)
- Consultants: Quality assurance/Quality systems (112 companies)
- Consultants: Registration/Submission assistance (58 companies)
- Consultants: Regulatory (111 companies)
- Consultants: Reimbursement (13 companies)
- Consultants: Technical documentation (78 companies)
- Design and Research and Development Services: Biocompatibility studies (13 companies)
- Design and Research and Development Services: Haemocompatibility studies (4 companies)
