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  • srg36 replied to the topic Discussion Topic: Post-market surveillance in the forum Device Documentation 7 years, 6 months ago

    I agree with the above posts regarding the strategies used in post market surveillance (PMS) as well as the benefits obtained from doing PMS. I would like to add to the conversation by describing another beneficial aspect of doing thorough PMS. Gathering information regarding product failures is the most important step of initiating a root cause investigation. When a trend is noticed in complaints received, and the complaints that were reported provide detailed information, it can help significantly narrow down the root causes and increase the speed of the investigation. It can also help you understand if your device failed because of misuse. If your company does not have a good PMS system it can be very difficult to get all the information required to do a thorough root cause investigation.