CE-Marking of Medical Devices and In-Vitro Diagnostic Medical Devices


According to the European Directives it is necessary to carry out a CE-marking process for each Medical Device and IvD Medical Device showing conformity with the European Directive and the Essential Requirements therein. Based on an analysis of your needs consulting & more will give You a complete and individual working plan to fulfill all legal requirements on the product and Your organization.

Focusing on new developed devices is as important as the work on already established products. consulting & more will support You in putting a product on the market as well as getting the established devices under the CE-mark. You will be perfectly guided through the actual regulatory for R&D, Technical Product File and Sales.

Fulfillment of the European Directives reduces Time to Market?!

Under the Directives 93/42/EEC and 98/79/EC a Technical File is required for each medical device including Risk Management, verification and validation data. It really makes sense to have a close look on the implemented processes while creating the above data. consulting & more will assist You in optimizing the processes and procedures if useful to shorten the future Time to Market of Your devices.

Doing all this it is necessary to keep the integrity of Your Quality Management System and the Risk Management process. consulting & more will also show You the links between the European Directives and the product marketing...

CE-marking process is different for each manufacturer!

Every company has individual structures and individual needs which must be combined with the requirements of the European and the individual National Laws. Although the MDD and IvDD define the requirements focusing on the devices themselves, the realization of the requirements in a start-up company will be different from the realization in a multi-national group company.

A very special topic of individuality will be the implementation of the Medical Devices Vigilance System in Your organization. We also support you as Safety Officer (Sicherheitsbeauftragter), following the Medical Device Law §30. Would you like to know more about the Safety Officer?

consulting & more would be pleased to share our longtime experience in CE-marking, Risk Management, Technical Documentation and Medical Device Vigilance with You and Your company. Let us work together on Your tasks for Your business advantage.

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