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

Journal: Technology and health care : official journal of the European Society for Engineering and Medicine
Published Date: Jan 1, 2023

Abstract

BACKGROUND: Dialysis machines are used regularly in healthcare practice. They are classified as a type of medical device with moderate and high risk therefore significant requirements are placed on their safety and performance every time they are used on patients. 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.
  • Dusanka Biskovic
    Faculty of Electrical Engineering, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.
  • Lejla Gurbeta Pokvić
    University of Donja Gorica, Podgorica, Montenegro.

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