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.
QAdvis EAR AB
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.
New member of our team – Maria Eklycke
Welcome Maria! Maria will be located at our Stockholm office, starting full time 26th of September, 2016.
IEC 82304-1 – Free breakfast seminar in Lund and Stockholm
Learn about the upcoming standard IEC 82304-1 “Health Software – Part 1: General Requirements for Product Safety” – a product standard for software-only medical devices. The seminar will be held in Lund 27 september and in Stockholm 29 september. For more information and registration follow the links below: Lund Stockholm
Internal Audit ISO 13485:2016 – Training
The course will be held in Lund, 13-14 October. For more information see the following link
MEDDEV 2.7/1 Rev. 4
The updated MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies has now been published