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
