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.
The 4th EAAR Annual Conference on New Medical Device Regulations
Robert Ginsberg, Chairman of the board at QAdvis and board member of European Association of Authorized Representatives (EAAR), is one of the speakers at RMD 2019. The event takes place in Brussels on 28–29 October, 2019, with an impressive list of competent speakers, including industry experts, and speakers representing EU Com, Notified Bodies, Legal and MedTech Europe. […]
We are pleased to share some great news about the further strengthening of our Quality and Regulatory team.
We welcome Caroline Ehrenborg MSc who has just started as a QA&RA consultant. She will be a great addition to our team and will support clients specifically with her competence within device/drug combination products. She is well versed within R&D, MDD and MDR Technical documentation, implantable devices and biocompatibility. It is also our pleasure to […]
International Medical Devices Exihibition (CMEF) 2019 on 11–13 July.
QAdvis EAR Manager, Bing Wu, will visit the 25th China (Shanghai) International Medical Devices Exihibition (CMEF) 2019 on 11–13 July. She will meet with many of the exhibitors, both Chinese and international visitors, as well as our customers. Read more about the exhibition here: http://www.chinaylqxexpo.com/English/index.asp
Lumito has chosen QAdvis to support them in the CE-marking
QAdvis has signed agreement with Lumito, developers of imaging techniques for both tissue in living organisms (in vivo) and tissue samples in laboratory environments (in vitro). Lumito intend to introduce their medical imaging solutions on the European market, and QAdvis will assist them in the regulatory work involved in implementing a quality management system and […]
Robert Ginsberg is a speaker at RMD2019-USA
Robert Ginsberg, Member of the EAAR Board and Chairman of the Board at QAdvis, Sweden, is one of the speakers at The American Conference on the New European Regulations of Medical Devices. The event takes place in New Jersey, USA on June 13–14, 2019. Robert’s speech will be on the 14th, 15:00–15:45, and he will speak about EU regulations on medical device software. You can […]