Advena will help you to achieve the regulatory and quality compliance required to bring your medical device or cosmetics products to market within the European Union (EU).
We specialise in simplifying regulatory compliance for small and medium-sized enterprises, with consultancy services tailored to your needs at competitive cost-effective rates.
Advena passionately believes that innovative small and medium-sized enterprises should be able to access the same standard of professional regulatory and quality expertise as multinational corporations.
We therefore take pride in providing a comprehensive and accessible service tailored to your needs – enabling you to avoid the overheads of recruiting specialist staff or the time and expense of continuously sourcing freelance expertise.
Established in 1996, we have completed a multiplicity of consulting projects across the world and actively manage over 125 contracted clients. We employ highly experienced practitioners with over 30 years experience in regulatory and quality affairs. Meet the Advena team >
Advena is certified by Lloyd’s Register (LRQA) for conformity to ISO 13485 for European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers. View our LRQA certificate >>
We are active members of the European Association of Authorised Representatives (EAAR), who have representatives on most of the major European medical device policy making committees. Advena are also members of the SGS Consultants Connect scheme and work with the West Midlands branch of Medilink, where we assist with training seminars. Advena also participates in the Medica trade fair each year.
Trusted Global Partners
Advena also has a range of trusted global partners to support clients who need the regulatory and quality compliance required to bring medical device products to market outside the European Union. Trusted Global Partners >
Advena’s headquarters are based in state-of-the-art offices in Warwickshire – located close to Birmingham International Airport and the heart of the UK’s road and rail networks. We also have a subsidiary office in Malta for EU Registrations.
Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – Advena are prepared, by active leadership from our dual locations, to assist medical device manufacturers wherever they are to practically and efficiently work through any political eventuality that Brexit may inspire. Please see our Brexit Information Portal >
On July 1st 2015 Advena Ltd acquired Medical Device & QA Services Ltd (MDQAS) – please see our MDQAS FAQ for further information >
Telephone: +44 (0) 1926 800 153