EU postmarket surveillance plans for medical devices.
Josep PaneReynold D C FranciscaKatia M C VerhammeMarcia OrozcoHilde VirouxIrene RebolloMiriam C J M SturkenboomPublished in: Pharmacoepidemiology and drug safety (2019)
The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
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