Regulatory approval for a broad range of new products

Regulatory Services

Regulatory services include FDA device clearance (510(k), PMA, etc.), CE marking (technical file preparation, post market activities, etc.), support in clinical trial approvals, clinical trial support and set-up and maintenance of quality management systems in our customers’ organizations. We support customers with regulatory approvals and country registrations in Europe, the United States, Canada, and elsewhere. Our long-standing working relationships with notified bodies support an early, collaborative assessment of regulatory strategies. For new start customers who do not yet have an ISO certified quality management system, we offer to hold regulatory approvals (e.g., CE mark) for products on behalf of our customers.

Location

Contract Medical International GmbH
Lauensteiner Strasse 37
01277 Dresden, Germany    

Contract Medical International, spol. s r.o.
Vazni 848, 500 03 Hradec Králové
Czech Republic

get in touch | send applications to

tel. +49 351 213 88 88 | fax +49 351 213 88 99
info@contract-medical.com

Dresden: jobs@contract-medical.com
Hradec Králové: jobshk@contract-medical.com

projects are supported by the eu