Our Services
Post-Market Surveillance
About this service
Post-Market Surveillance is a critical obligation for all medical device and PKRT distribution license holders to monitor product performance and safety after market launch. This process involves collecting, analyzing, and reporting data related to customer complaints, incidents, and Adverse Events (KTD). Naramedic provides comprehensive services to ensure your surveillance program runs effectively and complies with Ministry of Health regulations, protecting your brand reputation and user safety.
What You Get
Management of a structured Vigilance and Adverse Event (KTD) reporting system according to Ministry of Health standards.
Preparation of Post-Market Surveillance Plans & Reports.
Assistance in customer complaint investigation and root cause analysis.
Expert assistance during inspections or audits from regulators regarding post-market compliance.
Analysis of product safety data trends for preventive actions and continuous improvement.
Updates on the latest regulations regarding post-market obligations to keep you ahead in compliance.
Requirements
Download AttachmentActive Product Distribution License Data
Standard Operating Procedures (SOP) for Complaint Handling and Adverse Event Reporting
Product Distribution Data
Registered Technical Person in Charge
