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 device manufacturers.
As specialists in simplifying regulatory compliance for start-ups and small to medium-sized enterprises, our consultancy services are tailored to your needs at competitive cost-effective rates.
We are well pleased to provide you with consultancy services for the creation of your technical documentation (Technical Files) specifically for the UK market or if necessary one file that covers both the EU and UK markets. Please contact us for a free quotation.
In addition, for the UK market as part of the compliance process manufacturers located outside the UK must appoint a UK Responsible Person (UKRP), who must be located in the UK. The UKRP will register devices with the MHRA on behalf of the manufacturer.
As we are steeped in UK consultancy history, we have a partner in the UK whom we can introduce to you for this important and critical UKRP service.
For more information, please contact us.
