Whitepaper · 25 pages · free
Not sure what Agile looks like for FDA software?
A practical playbook for running sprints on regulated medical device software — and still producing the documentation, risk analysis, and traceability regulators (and patient safety) demand.
Regulated Agile Whitepaper · 2026
A practical guide from years in the trenches
Not sure what Agile looks like for FDA software?
How to run sprints and still produce the documentation, risk analysis, and traceability that regulators — and patient safety — demand. Grounded in real projects with real submissions.
What's inside.
Seven chapters grounded in real projects with real regulatory submissions — the workflows, roles, and artifacts we use every day. Not theory. Not a reframing of AAMI TIR45. The actual playbook.
01
What usually goes wrong Three recurring failure modes across startups and device manufacturers.
p.06
02
Thinking in layers Product, increment, and story — different work at different altitudes.
p.09
03
Definition of Done The compliance engine that makes story-level regulatory work happen.
p.12
04
The team: who does what Concurrent roles working in parallel within every sprint.
p.15
05
Documentation that builds itself The sum-of-the-parts approach to the DHF.
p.18
06
Design controls in an Agile world Inputs, outputs, V&V, risk, and cybersecurity.
p.21
07
Getting started What we do on day one of every engagement.
p.26
"Story-level work produces the evidence. Increment boundaries synchronize and review it. The DHF tells the same story the FDA expects to see — it was just built incrementally."