Person Responsible for Regulatory Compliance
One important new requirement in both MDR and IVDR is to have an assigned and dedicated Person ...
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News in medical technology
The new legislation on medical devices in the EU, MDR and IVDR has greatly influenced the need for ...
What is Eudamed?
Eudamed is an IT system developed by the EC to implement medical device and in vitro diagnostic ...
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 ...
QAdvis News #3 – 2020
Less than 9 months to go until Date of Application (DoA) for MDR, 26 May 2021. But is the DoA for ...
Update on situation with Covid-19
The ongoing situation with Covid-19, with the extended time range on recommendations to work from ...
QAdvis News #2 – 2020
MDR, IVDR, Health Apps Quality and Reliability, New consultants and highlights from QAdvis Academy ...
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 ...
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 ...