Abstract
Clinical decision rules (CDRs) integrated into applications enhance diagnostic and treatment prediction support for clinicians, necessitating Confirmité Europeenne (CE)-mark certification to enter the European market. We describe the development of a CDR as a medical device, focusing on challenges from a physician’s perspective exemplified by the Feverkidstool (FKT), a validated CDR for febrile children. We pursued a local process, aligned with the CE-marking process, to develop the FKT as in-house developed device. We aimed to provide a blueprint for colleagues. Medical device development, conforming the medical device regulation and performed by a multidisciplinary team, encompassed 5 stages: market scan, design, production, verification and validation and conformity assessment. Regulatory processes were continuously updated. The market scan identified a need for the FKT compared with existing applications. A prototype was designed in stage 2, further adjusted and improved based on the qualitative and quantitative results of stages 2-4. Lastly, stage 5 confirmed FKT’s performance and safety. Medical device development presents challenges for physicians, requiring collaboration for technical, regulatory, and financial expertise. Multidisciplinary teamwork also poses challenges, including uncertainties regarding responsibility and timelines. After CE certification, adapting to evolving needs and ensuring data privacy highlights the ongoing nature of medical device development.
Published Version
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