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Medical Device Ce Marking Services
3 services found
Manufactured by:ORGENTEC Diagnostika GmbH is part of the Sebia Group based inMainz, GERMANY
Our in vitro diagnostic medical devices (IVD) are CE marked. Our quality management system is certified according to ISO 13485 in the latest ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We have worked with numerous SMEs and Start Ups to develop their Quality Management System (QMS), Technical File and Risk Management Documentation to help them attain a CE Mark for their new medical device(s) in both a timely and cost-effective manner. We have experience of working with all classes of medical ...
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC ...