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MDR Certificate for Class IIb Medical Device
BAYOOCARE has received the MDR certificate for the class IIb medical device NeoDoppler in accordance with EU Regulation 2017/745. BAYOOCARE was certified by the notified body TÜV Süd.
This means that we are the holder of one of only around 1200 MDR product certificates in Europe to date. The cooperative team needed just 3 years to realise the project – from prototype to approval.
Thus, the class IIb medical device has now mastered another milestone on the way to final market launch. The NeoDoppler makes it possible to monitor the blood flow in the brain of premature or critically ill infants.
The cooperation was realised by BAYOOCARE GmbH (legal manufacturer), BAYOOMED GmbH (manufacturer of the software) Cimon Medical AS (copyright holder and spin-off of NTNU), Norbit (sample manufacturer), Aurotech AS (manufacturer of the ultrasound device), Bytech GmbH (manufacturing) and Mecora GmbH (packaging).
BAYOOCARE acts as the legal manufacturer of the medical device. In this position, we established, documented and implemented the quality management system (QMS) of the NeoDoppler in accordance with Article 10 (9) of EU Regulation 2017/745.
Legal Manufacturer as Service
We understand the task of legal manufacturers as a service and develop the appropriate launch strategy with you until the market launch of your medical device.
Are you planning a medical device in risk class IIa or IIb? We support you with your launch and use our accumulated experience.
Good to know: If damage occurs – whether to or through the medical device – we assume full product liability for you.
