A novel method for conformity assessment testing of defibrillators for post-market surveillance purposes.

Journal: Technology and health care : official journal of the European Society for Engineering and Medicine
PMID: 36530104

Abstract

BACKGROUND: Defibrillators are medical devices (MDs) used in the most critical situations, hence their performance must be ensured at all times. This requires defibrillators to be subjected to regular performance assessments after they have been placed on the market. The new Medical Device Regulation (MDR) defines medical device post-market surveillance (PMS) as performed by independent, third-party, notified bodies more strategically in hope to improve traceability of device performance. However, there is still an apparent gap in terms of standardised conformity assessment testing methods.

Authors

  • Almir Badnjević
    Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
  • Amar Deumic
    Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
  • Elma Imamovic
    Verlab Research Institute for Biomedical Engineering, Medical Devices and Artificial Intelligence, Sarajevo, Bosnia and Herzegovina.
  • Lejla Gurbeta Pokvić
    University of Donja Gorica, Podgorica, Montenegro.

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