News from QAdvis

IDL Biotech has chosen QAdvis for regulatory guidance and support

QAdvis has signed an agreement with IDL Biotech. We are proud to be a part of this exciting collaboration in which we will plan and conduct clinical studies for the IVD test UBC® Rapid. Based on the results, QAdvis will provide further regulatory guidance and support to IDL with the FDA application. As part of […]

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 […]