Medical Device Regulatory Affairs
Early Device DevelopmentClinical
StudiesRegulatory ApprovalPost-Market Support
StudiesRegulatory 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