Regulatory Affairs

Regulatory Affairs

Regulatory Affairs

The field of regulatory affairs "Regulatory Affairs" deals with everything concerning legal or normative requirements for placing medical devices on the market. From dealing with harmonized standards, to conformity assessment and post-market surveillance, RA experts are the point of contact for the requirements placed on these processes and activities by the relevant regulations for economic operators.

In Europe, these requirements are described in the MDR and IVDR, respectively.

The following pages describe how a device can be put on a wide variety of different markets worldwide. Often, a simple registration or confirmation of approval in the home market is sufficient. However, it can also be complicated; for example in China, the hurdles are particularly high. Additionally, in many African countries, a local contact is essential.

We will help you keep track of the different approval restrictions. Our experts know how to bring your product to market - whether in Europe, Asia or America.

 

Regulations for placing medical devices on the market

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On your questions about dealing with harmonized standards, conformity assessment, and post-market follow-up: Our RA experts have all the answers. Call now.

Contact +49 451 808 503 60