Regulatory Affairs

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Regulatory Affairs

Copenhagen

We are a group of like-minded professionals who have unique expertise that enables us to provide a holistic approach to your regulatory compliance in the field of medical devices and in vitro diagnostics.

Our ethos is to help patients, doctors, and society through our work. Therefore, we conduct ourselves honestly, ethically, and with pride – this is our company’s DNA.

Support regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.