MDR

For manufacturers of medical devices

Description

The Medical Device Regulation (MDR) imposes extensive requirements on all medical devices sold and marketed in Europe. For example, the MDR requires medical devices placed on the European market to be CE marked as proof that the product complies with the applicable regulations. The CE marking means, among other things, that the product meets the necessary safety and performance requirements.

Compliance with the MDR is an important part of ensuring the highest possible safety for both users and patients. For manufacturers, it is crucial to understand both the specific requirements and the process of achieving and maintaining CE marking, which includes everything from product development to aftermarket control.

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