Effective Requirements Engineering in Early-Stage Digital Health Startups

This case study examines the implementation of a requirements engineering process in early-stage digital health startups developing software as a medical device. We demonstrate a four-phase process that integrates systematic requirements gathering into product development while preparing for approval as a medical device. The study shows that even resource-constrained startups can effectively implement requirements engineering processes that support future regulatory compliance, potentially serving as a model for other digital health startups.