Browsing College of Engineering and Informatics by Author "Kearney, Breda"
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The challenges for manufacturers of the increased clinical evaluation in the European medical device regulations: A quantitative study
Kearney, Breda; McDermott, Olivia (Springer, 2023-05-17)The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates ...