Monitoring the safety and effectiveness of your medical device after it has been commercialized requires the implementation of effective Post Approval Support processes. These strategies and activities are specifically designed to ensure the ongoing compliance of your product(s). Regulatory Compliance Associates® (RCA) can help you design, implement, and execute a Post-Market Support Strategy including:
- Corrective and Preventive Action (CAPA) Support
- Root Cause Investigation
- Audit / Inspection Preparation and Remediation
- Labeling Review and Assessment
- Post-Market Surveillance (PMS)
- Medical Device Reporting / Adverse Event Reporting
- Recall Management
- Complaint Handling
- Re-submission Assessment and Remediation
- Post Approval Support
