A Strong Regulatory Focused Team Helping You Achieve EU Medical Device Compliance.
Advena was set-up in 1996 by John Adcock, first registered in 1998 as a UK business, have offered our EU Authorised Representative (EC REP) service from those very early years and today remains one of our key services. Along with the EC REP service, we offer regulatory consultancy services to many clients around the world whom we have helped achieve their regulatory goals by helping to carry the burden of responsibility with cost-effective regulatory services.
Since those early days Advena has grown and developed into a stronger regulatory focused business always looking in enhance the client experience. Of course, the UK is no longer part of the EU and as a result Advena went through a restructuring process that saw us relocate our business to the Island of Malta where we are now well established and have developed a good working relationship with the Malta Medicines Authority, the Competent Authority.
The business continues to drive forward from strength to strength thanks to a management team of experienced professionals with expert regulatory experience.
Accreditation
Advena Ltd have a formal Quality Management System and are certified by the Istituto Italiano del Marchio di Qualità (IMQ) for conformity to ISO13485:2016 for EU Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers.
It is also worth noting that IMQ are also a designated EU Notified Body.
View our IMQ certificate >>
Memberships
Advena Ltd is an active and founding member of the European Association of Authorised Representatives (EAAR), who have representatives on most of the major European medical device policy-making committees and working groups. We are also members of Medilink in the UK via our parent company. Advena Ltd also exhibits at MedTech World, MEDICA and at Arab Health trade show and visits other trade shows around the world.
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Meet the Team
Advena has developed and grown since originally set-up in 1996. We specialise in supporting start-ups and small to medium-sized manufacturers and employ a team who place the needs of our clients at the centre of our business.
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Malta Offices
Historically based in the UK but now firmly established in Malta (a full member state of the EU) we can guarantee representation to our clients as an EU Authorised Representative and a leading English-speaking international medical device consultancy firm.
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Trusted Globally
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.
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Client Testimonials
Visit our “Testimonials” page to hear firsthand experiences, genuine praise, and transformative journeys. Discover the impact our products and services have made and join our thriving community. Explore now and be inspired.
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