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.
Update on situation with Covid-19
The ongoing situation with Covid-19, with the extended time range on recommendations to work from home from Sweden’s Public Health Agency also maintains our limitations regarding visitors in our office premises. In order to eliminate any risk of QAdvis hosted events or QAdvis employees becoming a source of risk for clients and colleagues, we have […]
EU Parliament voted positively to the proposal of postponing the Medical Device Regulation for one year
On (17 April 2020), the EU Parliament communicated the outcome of positive voting session to adopt the Commission’s proposal to postpone the Medical Device Regulation by one year due to the Corona situation. New Date of Application will be 26 May 2021. The change will enter into force as soon as it is published in […]
EU Commission working on a proposal to postpone the new Medical Device Regulation for one year
Today (25 March 2020), the Commission announced that they are working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May. This decision will relieve pressure from national authorities, notified bodies, manufacturers and other actors and will allow them […]
Covid-19 situation statement
In the current situation with Covid-19, increasingly stricter national measures are being implemented to protect public health. The health and well-being of our colleagues, clients, friends and families are our first priority Please be advised. QAdvis will to the outmost extent support our clients and deliver according to plans. We strive to offer […]
2019 was an exciting year for us at QAdvis!
Hermine Redl, Office Manager, and Bing Wu, E.A.R. Manager and Quality and Regulatory Consultant at our Kista office and Caroline Ehrenborg, Quality and Regulatory Consultant at our Lund office are all very welcome new members on our team. We have taken part in a number of conferences this year, including RMD USA, RMD Europe, RAPS USA […]