Services
Quality
- Quality Management System (Establishment, Maintenance, Remediation)
- Training Implementation
- Internal / External Audit Support
- CAPA Management
- Field Actions (Corrections, Removals)
- Post-Market Surveillance
- Risk Management
Regulatory
- Regulatory Strategy
- FDA Warning Letter / 483 Responses
- Global Registration Support
- Technical File / Design History File Maintenance and Review
- Labeling, Promotion, and Advertisement Reviews
- Device Classification
- UDI Maintenance
Clinical
- Clinical Evaluation Support (CEP, CER)
- Management of Clinical Complaints or Adverse Events
- Clinical Input or Review for Product Design and Development
- Health Hazard Evaluations
- Clinical Advisory