... the advantages, challenges and critical success factors (CSFs) faced by medical device manufacturers when generating their clinical evaluation under EU-MDR 2017/745: Europe Systematic literature review Medical device Clinical trials Medical Device Regulations Medical devices represent a diverse...

...Beth Ann Fiedler; Robert J. Bebber Purpose The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic...

...Maysoun Dimachkie Masri; Bernardo Ramirez; Cristina Popescu; Ed Michael Reggie Purpose The aging of the population, high prevalence of chronic diseases, and increased need for evidence‐based practice are factors that have boosted a high demand for clinical trials in the United States. In recent...