How do you run sprints and still satisfy the FDA?
Every sprint produces working software and the evidence regulators expect — requirement, design, tests and risk, story by story.
The model, in four moves.
A teaser of the methodology we bring to every engagement — the full playbook is what we build with you.
Think in layers.
Strategic decisions at the product layer. Synchronization and formal reviews at increment and release boundaries. Day-to-day regulatory work inside every story. Different deliverables belong at different levels — mixing them up is how teams end up doing Waterfall in sprint-sized chunks.
The Definition of Done is the gate.
Approved requirement, documented design, traced tests, peer-reviewed code, updated risk assessment — a story that misses any of these isn’t done, period. It’s the mechanism that makes regulatory work happen at the story level instead of getting deferred.
Documents assemble from parts.
No monolithic SRS written in one heroic sitting. Each story emits versioned, approved parts into a controlled repository; at increment boundaries the full documents are assembled — largely mechanically. Documentation stays current, reviews stay small, traceability is built in from the start.
repository
The whole team works concurrently.
Developers, tester, architect, RA/QA, UX and cybersecurity work in parallel within every sprint — on different stories at different stages. RA/QA isn’t a downstream gate; they’re in planning, running risk sessions, reviewing artifacts as they’re produced.
Process, not good intentions.
Our sprints run under SOPs backed by a QMS, with tooling that keeps traceability as objective evidence from day one. Compliance isn’t retrofitted — the records exist because the process produced them, reviewed and approved as the work happened.
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