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, ...
QAdvis to participate in RMD2016 in Prague
The European Symposium on The New Agreed Draft Regulations on Medical Devices, organized by EAAR, ...
QAdvis EAR AB
QAdvis EAR AB, a subsidiary to QAdvis AB, has been established in August 2016. The business in ...
IEC 82304-1 – Free breakfast seminar in Lund and Stockholm
Learn about the upcoming standard IEC 82304-1 “Health Software – Part 1: General Requirements for ...
Internal Audit ISO 13485:2016 – Training
The course will be held in Lund, 13-14 October. For more information see the following link
MEDDEV 2.7/1 Rev. 4
The updated MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies has now ...