CLIENT Small Medical Device Manufacturer (<200 employees) Company Stage: Two hardware products launched; working on their first digital health product (SaMD) CHALLENGES Client had no experience with mobile or cloud software; relied 100% on development partner Software development partner had no experience with medical devices and regulations; they were making undocumented and uncontrolled changes to […]

CLIENT  Small Medical Startup (<10 employees) Company Stage: Developing digital health product (SaMD) CHALLENGES Client staff consisted of physicians and engineers who had no experience with medical devices and regulations Aggressive timeline for software development, testing, and FDA submission No quality system and no head of quality SOLUTION Used a staged implementation for quality system