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.
Final draft texts of MDR and IVDR
The final draft text of MDR is available through this link. And the final draft text of IVDR is available through this link.
Presentation materials now available on our web page
Materials from breakfast seminars and webinars can be found at this link.
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.