PMP Guide — Empowering Project Managers
ProcessAgileHardECO: Process Task 14.3

PMP Practice Question: Process — Agile, Hard

Your agile project team is developing a medical device software component that requires FDA regulatory approval. You're using two-week sprints with a definition of done that includes unit tests, integration tests, and code review. The regulatory affairs department insists that no code can be released to production without completing a validation protocol that takes 6-8 weeks and costs $50,000 per validation cycle. Marketing is pressuring for faster feature delivery to respond to competitive threats. The team is frustrated because completed increments sit unreleased for months. How should you adapt your agile approach to balance regulatory compliance with agile principles?

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