Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations

Caring for a child in life-threatening distress is very stressful and error-prone for the caregivers. An end-user need for a software that would free the child from human error and support the caregivers in the care of the child has thus emerged. Free from the time-consuming and stressful constraints of calculating constants or medication doses and consulting emergency protocols, caregivers could be more available and focused on the vital care of the child. The extension of the scope of medical devices to software for medical purposes is one of the important new points of the future European regulations. The very important overhaul of the previous classification system with the addition of new rules or updating of old ones reinforces the regulations applicable to software. The impact is considerable for the development and market access strategy of highrisk classified software, and participate in a better security and efficacy of the marketed products, for better healthcare. In this article we propose then to detail the strategy used for the development of a high-risk medical device software intended to be used in pediatric intensive care units.