Advena Limted

Advena’s professional EU Authorised Representative service reduces the complexity of compliance for start-ups and small to medium sized non-European enterprises providing a gateway for exporting medical devices into Europe. Advena also specialise in providing regulatory consultancy for all aspects of medical device regulatory approval. Their all-inclusive regulatory support includes assistance with EU Technical Files. Advena’s experts will help you create and operate an efficient quality management system to support ISO 13485 and is simplified by the ACTIV online management system. Advena also assist businesses in meeting the regulatory requirements of the EU Cosmetics Regulation.