Regulatory consulting

We support our customers with meeting regulatory requirements of medical and in-vitro diagnostic devices. Our expertice is focused on devices, accessories and software regulated under MD-, IVD- and AIM-directives and the new regulation (MDR and IVDR). We also support companies with their MDR transformation projects.

Our service offering

  • Clinical evaluation
  • Support with compliance issues, including MDD to MDR transformation projects
  • Support with device classification
  • Support with risk management
  • Support with incident reporting procedure
  • Support with Quality Management System build-up
  • Support with CE marking
  • Quality Manager service

Contact us!