We welcome a new team member – Cristina Barkman
Cristina has a solid academic and industrial background, entirely focused around medical devices. ...
We are delighted to welcome Ekaterina Riabova to our team
Ekaterina is located at our Lund office. She brings many years of medical device experience to our ...
QAdvis enters partnership with Everdon Security
QAdvis has signed letter of cooperation with the Swedish cyber security company Everdon Security. ...
Meet QAdvis at RAPS in Washington
QAdvis is an exhibiter at the “The annual Regulatory Convergence in Washington” September 9th – ...
Robert Ginsberg speaker at RMD Europe 2017
Robert Ginsberg is a speaker at the 2nd European Symposium on The New Agreed Draft Regulations on ...
The new regulations on medical devices are now published in the Official Journal of the European Union
The texts are available following this link. The Medical Devices Regulation is identified as ...
Positive vote in the European Parliament on 5th April regarding EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR)
The regulations will entry into force 20 days after publication in the EU Official Journal. ...
Final draft texts of MDR and IVDR
The final draft text of MDR is available through this link. And the final draft text of IVDR is ...
IEC 82304-1:2016
The new standard IEC 82304-1, Health software — Part 1: General requirements for product safety, ...