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  • sns34 replied to the topic Discussion Topic: Post-market surveillance in the forum Device Documentation 8 years, 1 month ago

    The FDA uses post-market surveillance to monitor the safety and effectiveness of medical devices once they are on the market. It is a regulatory requirement and a system that provides continuous feedback about the device on the market in order to maintain a high standard of product quality. Thus, the feedback and data that is collected is very important for the success of a company. Post-market surveillance can be carried out in several ways: monitoring of manufacturing performance (are there defects or issues with the manufacturing of the product?), monitoring of product failure, and data collection and analysis of customer complaints and feedback.