We continue to work with a number of trusted global partners, whom we have long standing relationships with. This enables us to ensure we can support clients who need regulatory and quality compliance outside of the UK and European Union, including our partner Advena Ltd (Malta), who offer EU Authorised Representative Services and both Medical Device Regulatory and Quality Management support to manufacturers based outside of the UK and European Union. Please visit www.advena.mt for more details of their services.
Cosmetic UK Responsible Person Before your product can be placed on the UK market it must meet Regulation (EC) No
Advena are the only consultancy team you need to bring your medical device through the ever changing regulatory hurdles to
In order to place a medical device/IVD on the GB market, manufacturers based outside of the UK must appoint a
Advena’s ACTIV system A full ISO 13485: 2016 system requires many different procedures and record types to be compliant, all
Internal Audits To ensure impartiality and compliance, Advena are able to offer a tailored auditing service to the challenging requirements
The world of Medical Device and In Vitro Diagnostic regulations is complex. Your team need to understand the entire process,
Advena are the only consultancy team you need to bring your IVD through the ever changing regulatory hurdles to approval.
A quality management system (QMS) is defined as a system of processes that ensures a high-quality approach and consistent results
MDSAP is a single audit of your QMS by a recognised certification body, that aims to ensure the requirements of