ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. ...
The collection and evaluation of sound clinical data are the basis of the approval process for many medical devices. This paper outlines those topics that a sponsor must carefully consider in an effort to provide a meaningful evaluation and interpretation of clinical data in support of medical device Premarket Approval applications (PMA).ادامه مطلب
Many people colloquially refer to “clinical trials” as the source for clinical data for efficacy of treatments, where the trial is the activity of testing a medical device with patients to confirm that it provides clinical benefits. ...ادامه مطلب