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Are you ready for the new EU Regulations for Medical Devices and In Vitro Diagnostics
White paper written by Qarad in cooperation with CPSL. June 2018
Revision of Europe’s IVD Directive 98/79/EC
Article written by Dirk Stynen for IVD Technology. July 2011
Making instructions for use available in Europe
Article written by Dirk Stynen, Ph.D. for IVD Technology. May 2009
Classification rules under IVDR
ISO 13485:2016 Certificate
Qarad is an ISO 13485:2016 Certified company
ISO 27001:2013 certificate
As ISO 27001:2013 certified company, we comply to the high standards for Information Security
Don’t hesitate to contact us if you need help with the interpretation with one of these documents!