13.07.2015 Views

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>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> :“<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> <strong>is</strong> a systematic procedure toreview experience gained from devices in the postproductionphase.”Source: Europe (Directives & MEDDEV 2.12)

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