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Sanam replied to the topic Discussion Topic: Post-market surveillance in the forum Device Documentation 7 years, 2 months ago
PMS is a collection of processes and activities used to monitor the performance of a medical device.PMS can improve device,provide better services to users and reduce the risk of adverse events before it happen.If manufacturer introducing new technology ,should respond with an increased monitoring program to ensure early detection of problems.Post market clinical follow up may be warranted to success of real world use of device.PMCF is an important part of PMS .PMCF is active collection of data on clinical experience after market release Pre market phasemay be too limited to identify rare events.PMCF is crucial to identify new and unknown risks.Customer complaints are the indicator of product quality.Every complaint must be evaluated ,investigated and when necessary corrected.