Medical Devices and IVD Devices

Biomapas provides full scope regulatory affairs services for Medical Devices and In Vitro Diagnostic Devices. This includes:

  • Clinical Evaluation of Medical Devices
  • CE Marking Consulting for Medical Devices and IVDs
  • Guidance on medical device classification
  • Consulting on the European Medical Devices Directives
  • Technical File Preparation for Medical Devices and IVDs
  • Interaction with and documentation preparation for Competent Authorities
  • Clinical Evaluation Reports for Medical Devices

Biomapas also offers Clinical Evaluation and Materiovigilance services on Medical Devices.

For any inquiry regarding our services, please contact Biomapas Business Development team.