News from QAdvis

QAdvis wishes all our customers a Merry Christmas and a Happy New Year!

We refrain from physical christmas gifts and choose to support the Swedish Childhood Cancer Foundation (Barncancerfonden) in their effort to prevent and combat cancer diseases in children.

New member of our team – Anneli Wiedenkeller

Welcome Anneli! Anneli is located at our Stockholm office, starting full time 5th of December, 2016.

QAdvis to participate in RMD2016 in Prague

The European Symposium on The New Agreed Draft Regulations on Medical Devices, organized by EAAR, takes place in Prague next week. QAdvis is represented among the speakers by Robert Ginsberg who will talk about medical device software and upcoming challenges within this field.

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.