Advena Ltd (Malta)

Advena was set-up in 1996, first registered in 1998 as a UK business, and have offered our EU Authorised Representative (EC REP) service to medical device & IVD device manufacturers from those very early years, today it remains one of our key services. Along with the EC REP service, we offer medical device & IVD device 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. Our services include the EU authorised representative services, regulatory & quality consultancy for medical devices & IVD devices, device registrations, training, and support concerning EUDAMED.