ISO 13485:2016 requirements

Strasbourg, January 10th 2018:

Defymed is proud to announce that its quality management system was assessed by LRQA and is compliant with the ISO 13485:2016 requirements. This new certification is crucial for medical devices manufacturers since it will enter in force on March 2019 and also because it has been reviewed to match the Medical Device Regulation that will be applicable starting May 2020. Defymed has chosen LRQA since it is part of the 24 notified bodies members of the Team NB, and since it has put in place good practices, which totally comply with Defymed’s regulatory requirements. This approval is a great recognition of the efforts deployed by Defymed to deliver high quality and safe medical devices.

Link to our ISO 13485:2016 certificate