Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
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Introduction: GHTF Guid<strong>an</strong>ce on <strong>Post</strong> <strong>Market</strong><strong>Surveill<strong>an</strong>ce</strong> <strong>an</strong>d <strong>Adverse</strong> <strong>Event</strong> <strong>Reporting</strong>M<strong>an</strong>ufacturers system for post-marketing surveill<strong>an</strong>ce• PMS implemented <strong>an</strong>d operational PRIOR to marketing• Process includes:• complaint h<strong>an</strong>dling,• post-market vigil<strong>an</strong>ce reporting (AE <strong>Reporting</strong>),• subsequent CAPA• RA / CAB verifies the PMS process during Audit of QMS / GMP.• RA may require specific post-marketing study of a particulardevice.• The RA monitors post-marketing study - dec<strong>is</strong>ion on RegulatoryAction.Source: Principles of Conformity Assessment for Medical Devices SG1 Final Document GHTF/SG1/N78:2012
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