A novel method for conformity assessment testing of infant incubators 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: Premature born infants or infants born sick require immediate medical attention and decreasing the stress imposed onto their body by the environment. Infant incubators provide an enclosed environment that can be controlled to fit the needs of the infant. As such, their performance must be consistent and without significant deviations. The only manner to ensure this is by post-market surveillance (PMS) focused on evaluation of both safety and performance. 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.