Medical Device Post-Market Surveillance Audit Checklist

A comprehensive checklist for auditing post-market surveillance processes in medical device companies, ensuring compliance with ISO 13485 standards and improving ongoing product safety and performance monitoring.

Medical Device Post-Market Surveillance Audit Checklist
by: audit-now
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About This Checklist

The Medical Device Post-Market Surveillance Audit Checklist is a vital tool for healthcare organizations to ensure ongoing compliance with ISO 13485 standards after product launch. This comprehensive checklist focuses on monitoring the safety and performance of medical devices in real-world settings, helping manufacturers identify and address potential issues promptly. By implementing robust post-market surveillance processes, companies can enhance patient safety, maintain regulatory compliance, and continuously improve their products. This checklist aids in systematically evaluating data collection methods, complaint handling procedures, and adverse event reporting, ultimately contributing to better healthcare outcomes and reduced risks associated with medical device use.

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Industry

Healthcare

Standard

ISO 13485

Workspaces

Medical Device Manufacturer Headquarters

Occupations

Quality Assurance Specialist
Regulatory Affairs Manager
Clinical Affairs Specialist
Product Safety Officer
Post-Market Surveillance Coordinator

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