Jeff Lee

Software teams inside FDA-regulated environments often struggle with slipping release dates and long, unpredictable V&V cycles before launch. In this case study with Smith+Nephew, we examine how three software teams improved predictability and transparency within design controls. By redefining “done,” integrating quality activities into each sprint, and creating clearer release evidence throughout development, the teams reduced the regulatory tail at the end of projects and established more regular, reliable release cycles. Attendees will leave with practical steps for improving audit confidence, increasing delivery transparency, and making predictable software releases possible inside a QMS.