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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<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> & <strong>Adverse</strong><strong>Event</strong> <strong>Reporting</strong><strong>What</strong> <strong>is</strong> <strong>an</strong> “<strong>Adverse</strong> <strong>Event</strong>”:“An <strong>Adverse</strong> <strong>Event</strong> <strong>is</strong> either a malfunction or a deterioration in thecharacter<strong>is</strong>tics or perform<strong>an</strong>ce of a sold medical device [includingaccessory(s) <strong>an</strong>d labelling] or use error, which either has caused orcould have caused or contributed to death, or serious injury tohealth of patients or other persons.”Source: GHTF/SG4/N33R16:2007 & Definition <strong>an</strong>d Glossary of Terms Used in GHTFDocuments GHTF Steering Committee Final Document GHTF/SC/N4:2012 (Edition 2)NB ! : There are more specific GHTF definitions when including “ClinicalInvestigations” in the scope of the definition.
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