Post Market Surveillance & Adverse Event Reporting What is an

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Life cycle of medical devices & Principal StakeholdersUseRefurb.DisposalU, M,RA,HSUseDEVMFGM & S- User / patients use the MD andreport Adverse Events- MFG surveys his product &product environment andreports- RA monitors, surveys themarket and enforces Reg.Action- HC system reimburses (or not)and surveys “efficacy” andliaises with RA
Life cycle of medical devices & Principal StakeholdersDisposalDEV- Manufacturer refurbishes- RA / CAB assesses conformityof refurbished“Result” and verifies GMPUseRefurb.M,RA/CABUseMFGM & S
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Post Market Surveillance & Adverse Event Reporting What is an

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