Device Vigilance Report Preparation and Submission
Preparation and submission of medical device vigilance reports in compliance with applicable global and local regulatory requirements.
Adverse Device Effect (ADE) / Medical Device Incident (MDI) Trending and Evaluation
Systematic analysis and trending of device-related adverse events and incidents to support risk assessment and regulatory compliance.
Vigilance Quality Assurance Including SOP Development
Quality assurance support for vigilance systems including SOP development, process compliance, and audit readiness activities.
ADE and MDI Reconciliation
Accurate reconciliation of adverse device events and medical device incidents across multiple data sources to ensure data consistency and completeness.
