This white paper from EMMA International – an associate member of AdvaMed – discusses the quality and regulatory approach for medical devices and software tools that contain AI/ML-based software. It also explores a case study for developing a Next Generation (NGen) eQMS. The case study focuses on how an eQMS could be integrated with modern technologies to deliver a full-fledged software product. The white paper also discusses the standard software validation principles that describe what activities manufacturers should implement to ensure their software is compliant with the required regulations.