Advena is able to provide expertise on all aspects of the in-vitro diagnostic medical device Directive 98/79/EC (IVDD) regulatory approval system. Our all-inclusive regulatory support includes assistance with EU Technical Files and a professional Authorised Representative service.
Advena is certified by Lloyd’s Register for conformity to ISO 13485:2016 for European Authorised Representative services, 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 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, here.
For more news on IVDs, visit our News section. You can see our latest post on the IVD regulation, here.
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Telephone: +44 (0) 1926 800 153