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CE Marking Services

Description courte

CE Marking Services assist in obtaining approval for medical devices to be sold in the EU, verifying compliance with safety and quality standards.

Description longue

 

CE Marking Services guide manufacturers through the process of obtaining CE marking for their medical devices, ensuring compliance with EU regulations. This includes assessing the device’s conformity with essential requirements, compiling technical documentation, and, if necessary, involving a notified body for conformity assessment. By obtaining CE marking, manufacturers demonstrate that their devices meet high standards of safety, health, and environmental protection, enabling them to market their products within the European Economic Area (EEA).