Post Market Surveillance & Adverse Event Reporting What is an

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Post Market Surveillance and Adverse Event reportingManufacturers marketing Medical Devices in EUPost Market Surveillance actions of manufacturers required inthe Medical Device Directives :• Obligation to have a systematic procedure to reviewexperience gained from devices in the post-production phase• Obligation to implement Corrective Action• Obligation to inform competent authorities (Adverse EventReporting)Pro active actions of manufacturers required by applicable ISO13485 clauses. (Feedback)
Post Market Surveillance & Adverse Event Reporting
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