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 – <strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> & <strong>Adverse</strong> <strong>Event</strong><strong>Reporting</strong>Conformity assessment:“Conformity assessment, conducted before <strong>an</strong>d after a medicaldevice <strong>is</strong> placed on the market, <strong>an</strong>d post-market surveill<strong>an</strong>ce ofdevices in actual use are complementary elements of the GHTFglobal regulatory model. They are intended to provide theobjective evidence of safety, perform<strong>an</strong>ce, <strong>an</strong>d benefits <strong>an</strong>d r<strong>is</strong>ksto maintain public confidence.”Source: section 2.1 - Principles of Conformity Assessment for Medical Devices SG1 FinalDocument GHTF/SG1/N78:2012
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