A Blueprint for Clinical-Driven Medical Device Development: The Feverkidstool Application to Identify Children With Serious Bacterial Infection.

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-ho