Advena History & Future
Set-up in 1996 by John Adcock, and first registered in 1998 as a UK business, we have completed a multiplicity of consulting projects across the world have actively manage well over 300 contracted clients during our 20 years of service. We employ highly experienced consultants with over 35 years’ experience in regulatory and quality affairs. Meet the Advena team >
In March 2014 Advena Ltd set-up a second business, Advena Medical Ltd. with Kirsty Ostle at the helm, to specifically service clients based in the UK and EU. This left the original business, Advena Ltd, to service clients outside of the EU. However, the business is continually evolving and with the changing political landscape and the potential disruption of Brexit, in August 2016, Advena Ltd set-up a business in Malta in order to protect clients from the potential impact Brexit may have. Following on from this Advena Ltd & Advena Medical Ltd decided to merge and trade under the one name, Advena Ltd, with offices in the UK and Malta.
Driving the business forward, Kirsty Ostle has become the Managing Director of Advena Ltd UK, while Anthony Kirby has been appointed the Managing Director of Advena Ltd Malta, with John Adcock taking up the role of Chief Executive Officer. Despite these two businesses having their own client portfolios they share senior business services, consultant services, this website and over 20 years of medical device regulatory expertise.
Advena Ltd have a formal Quality Management System and are 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. View our LRQA certificate >>
Advena Ltd 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 and are members of the GMDN Agency. Both businesses 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 Ltd also exhibits at the Arab Health show in Dubai each year.
Trusted Global Partners
As international medical device consultants we work closely with several trusted global partners to support clients who need the regulatory and quality compliance outside the European Union. Trusted Global Partners >
Our UK office is in a suite of modern offices in Warwickshire and located close to Birmingham International Airport and the heart of the UK’s road and rail networks. While our Maltese office is based in equally modern offices in the Republic of Malta, with its own on-site team dealing with medical device registrations and consultancy services.
Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – Advena have now expanded and are operating from both the UK and Malta to assure clients, wherever they are, to practically and efficiently work through any political eventuality that Brexit may inspire. Please see our Brexit Information Portal >
In 2015 we acquired Medical Device & QA Services Ltd (MDQAS) and are always actively looking to grow our portfolio internationally and are always happy to talk to business who may want to join us in our exciting future.
Advena function as an expanding and forward thinking business and understand that medical device regulation will never go away with growth being an almost certainly.
Telephone: +44 (0) 1926 800 153