Clinical and Regulatory Services for Medical Devices

Medical Device Regulatory Affairs

Early Device DevelopmentClinical
Regulatory ApprovalPost-Market Support

Early Device Development

  • Clinical and regulatory strategy
  • Trial design and validation
  • Quality systems
  • Risk management
  • Early feasibility studies

Clinical Studies

  • Medical Affairs
  • Regulatory Affairs and medical writing
  • Clinical monitoring
  • Clinical trial management
  • Biometrics and data sciences
  • Safety and CEC/DSMB
  • Quality assurance
  • Core labs

Regulatory Approval

  • Clinical study reports
  • Literature reviews
  • Market approvals
  • EU authorized representative

Post-Market Support

  • Post-market registries
  • Health economic assessments
  • Manuscript support
  • MDR and vigilance reporting