Advena provides expertise for all aspects of the medical device regulatory approval cycle. Our all-inclusive regulatory support includes assistance with EU Technical Files and a professional EU Authorized Representative service.
Advena is certified by British Standards (BSI) for conformity to ISO 13485 for European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers.
As specialists in simplifying regulatory compliance for small and medium-sized enterprises, our consultancy services are tailored to your needs at competitive cost-effective rates.
Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – we are able to assure all clients, existing and new, that Advena will continue to lead by being a prominent English speaking international medical device consultancy uniquely based in the UK with a subsidiary office in Malta for EU registrations. For further information, please see our Brexit information portal >
Contact Advena today for a FREE initial consultation:
Telephone: +44 (0) 1926 800 153