QAdvis EAR AB, a subsidiary to QAdvis AB, has been established in August 2016. The business in QAdvis EAR is focused on European Authorized Representative services for non-EU based medical device manufacturers. This setup simplifies our business structure, where QAdvis EAR represents the manufacturers in contacts with national Competent Authorities within EU and EEA.
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.