Post Market Surveillance & Adverse Event Reporting What is an

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Life cycle of medical devices & Principal Stakeholders- User disposes off- Manufacturer takes part inrecycling- RAE (e.g. environmental)legislates, surveys andenforcesUseRefurb.DisposalU, M,RAEUseDEVMFGM & S
Introduction – Post Market Surveillance & Adverse EventReportingConformity assessment:“Conformity assessment, conducted before and after a medicaldevice is placed on the market, and post-market surveillance ofdevices in actual use are complementary elements of the GHTFglobal regulatory model. They are intended to provide theobjective evidence of safety, performance, and benefits and risksto maintain public confidence.”Source: section 2.1 - Principles of Conformity Assessment for Medical Devices SG1 FinalDocument GHTF/SG1/N78:2012
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