UK Medical Device Consultancy Services
Advena provides expertise in all aspects of the medical device regulatory approval cycle. Our all-inclusive regulatory support includes assistance with UK Technical Files and ISO 13485:2016 Quality Management Service. Advena is certified by IMQ for conformity to ISO 13485:2016 for European Authorised Representative service, quality management, regulatory affairs, and document creation and control for medical ...
UK Responsible Person
Since the UK is no longer a member of the EU, medical device manufacturers must now follow the UK’s medical device regulation in order to place medical devices on the UK market. One of the requirements is to appoint a UK Responsible Person, who is physically located within the UK. The UK Responsible Person’s responsibilities ...
