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Regulatory Affairs

Not only are regulatory requirements numerous, they are constantly changing and need to be fulfilled.  The new Medical Device Regulation (EU) 2017/745 apply to the market launch of medical devices of all risk classes. The coordination of different departments, responsibilities and tasks poses an enormous challenge. We work together with the various departments of our customers to meet and overcome this challenge.

We support you in preparing necessary documentation for national and international authorities. In doing so, we take an objective look at your technical documentation and identify possible inconsistencies or inaccuracies regarding content that could delay the approval process for the target market. Based on the requirements of currently valid regulations, we prepare or revise your documents. For this purpose we bundle our experience and your competence. Together we achieve the goal of market access for your product and adapt our cooperation to your individual wishes and needs.

We offer:

We support you competently, reliably and individually in the following areas:

  • Preparation of the biological assessment
  • Support with risk analysis and instructions for use
  • International regulatory affairs:  Development of international regulatory strategies, preparation of files to be submitted and communication with competent authorities.


Contact your novineon specialist.

Phone: +49 7071 98979 – 127