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Medical Device Regulatory Consultancy Services

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 Authorised Representative service.

We also provide a comprehensive range of quality management services, including support for the set-up and organisation of ISO 13485 quality systems.

Advena is certified by Lloyd’s Register (LRQA) for conformity to ISO 13485:2016 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 >

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