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>an</strong>d <strong>Adverse</strong> <strong>Event</strong> reportingM<strong>an</strong>ufacturers marketing MD in C<strong>an</strong>ada:<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> actions of m<strong>an</strong>ufacturers required inthe Medical Device Regulations under:• D<strong>is</strong>tribution records• Complaint h<strong>an</strong>dling• M<strong>an</strong>datory Problem <strong>Reporting</strong> (<strong>Adverse</strong> <strong>Event</strong> <strong>Reporting</strong>)• Recall– Those activities are not called “<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong>”Pro active actions of m<strong>an</strong>ufacturers required by applicable ISO13485 clauses – but not called <strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong>
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