PMP Practice: Determine potential threats to compliance

Tomáš Kovář-Novotný is managing a project for Tahini Supernova Studios to develop a medical diagnostic device. The project involves hardware design (requiring strict FDA regulatory submissions at defined gates) and companion software (which will be updated continuously post-launch). During planning, the compliance officer emphasizes that FDA submissions require complete documentation packages with locked specifications at three regulatory milestones. Meanwhile, the software team wants to use iterative sprints to incorporate user feedback from clinical trials. The executive sponsor asks Tomáš to recommend an approach that satisfies both regulatory requirements and allows for rapid software evolution. What approach should Tomáš MOST appropriately recommend?