IEC 82304-1:2016

The new standard IEC 82304-1, Health software — Part 1: General requirements for product safety, has been published.

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