Medical Device Regulation
Advena are the only consultancy team you need to bring your medical device through regulation and into use.
As specialists in simplifying regulatory compliance for small and medium-sized enterprises, our consultancy services are tailored to your needs at competitive cost-effective rates. We provide expertise for the full medical device regulatory approval cycle, including assistance with EU Technical Files and a professional EU Authorised Representative service. Our comprehensive quality management services include support for the set-up and organisation of ISO 13485 quality systems.
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.
We ensure your device meets the regulations it needs to, help to train your existing staff. Working with you we create an implementation plan including timescales involved and ensuring the process is cost-efficient.
The key areas to consider are:
Our aim is to simplify the regulation process, giving you full confidence you will be compliant with the regulations.