Browsing by Subject "Clinical trials"
Now showing items 1-2 of 2
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The challenges for manufacturers of the increased clinical evaluation in the European medical device regulations: A quantitative study
(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 ... -
Gene therapy in transplantation: Toward clinical trials
(Thompson, 2009)The genetic modification of organs or cells is an attractive approach to protect allogeneic transplants from acute rejection and other complications. The transplant setting offers a unique opportunity to utilise ex vivo ...