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.
We at QAdvis want to wish you a joyful holiday season and say thanks for what we have achieved together throughout the year. As a part of the Labquality family we look forward to continuing our journey with all clients, colleagues and partners in 2025. Contact us if you need more information or hands on assistance.
Compliance with ISO 13485 and EU MDR/IVDR require clear evidence of effective control over measuring and monitoring processes, equipment, and calibration—a requirement that is easy to underestimate or overlook. EN ISO 13485:2016/A11:2021 contains a section (7.6) dedicated to the control of monitoring and measuring equipment, which includes both a determination of the monitoring and measurements […]
Human Factors Engineering (HFE) or Usability Engineering (UE) isn’t just about functionality and regulatory compliance, it’s about ensuring that devices are safe and easy to use for the end users by understanding human capabilities and limitations. The evolution of usability guidelines and standards for medical devices highlights an increasing recognition of the crucial role human […]
International Congress on Quality in Laboratory Medicine and Health Tech Labquality Days is one of Northern Europe’s largest annual international congresses focusing on quality in laboratory medicine and health technology. The inspiring atmosphere of the annual scientific congress gathers medical laboratory and health technology professionals together to exchange ideas and meet colleagues. Theese days brings […]
The EU Commission is urged to propose solutions by no later than the end of Q1, 2025. The revisions will seek to address the many challenges and bottlenecks associated with placing and maintaining medical devices within the EU market, particularly from the perspective of manufacturers and notified bodies (NB) in ensuring timely access to safe […]