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Post Market Surveillance (PMS)

Post-market surveillance is the phase after initial medical device approval by the manufacturer and the associated permanent monitoring of the medical device. The manufacturer is required to actively obtain comprehensive information about usage in order to record any anomalies and, if necessary, to inform patients and authorities of any corrective and preventive measures that may be required. The PMS process is part of the medical device manufacturer’s quality management system and includes the collection of quality and safety data as well as the risk class of the medical device. This data must be actively analyzed and updated throughout the product life cycle.  The goal of PMS is to protect society by ensuring manufacturers that their devices provide the intended benefit while avoiding unexplored, life-threatening risks. 

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Sven J. Kolthof



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