Post Market Surveillance & Post Approval Support
Post Market Surveillance & Post Approval Support
FiunEx's Post Market Surveillance and Post Approval services are designed to help you maintain the highest standards of safety and quality while meeting all regulatory requirements in the dynamic and evolving landscape of medical devices and IVDs. FiunEx offers a comprehensive range of Post Market Surveillance and Post Approval services for Medical Devices and In Vitro Diagnostics (IVD) to ensure the ongoing safety and compliance of your products.
Services
Post Market Surveillance
PMS System Implementation
PMS Plan Development
PMS Reporting
PMS Audits
Data Collection and Analysis
Risk Assessment and Management
Post-Market Clinical Follow-up (PMCF)
Quality System Integration
Regulatory Compliance Support
Continuous Improvement Initiatives
Post Approval Support
Corrective and Preventive Action (CAPA) Support
Root Cause Investigation
Audit / Inspection Preparation and Remediation
Labelling Review and Assessment
Post-Market Surveillance (PMS)
Medical Device Reporting / Adverse Event Reporting
Recall Management
Complaint Handling
Re-submission Assessment and Remediation