About
FWL.ai is a Regulatory & Quality RegTech practice built around one principle: compliance only scales when outputs are repeatable, traceable, and defensible under audit.
What we do
- Convert regulatory work into repeatable, reviewable operations.
- Reduce avoidable rework by defining gates, acceptance criteria, and versioned outputs.
- Deliver handover-ready packs (checklists, manifests, and controlled change logs) built to survive audits.
How we work
- Acceptance criteria first (what “done” means is written before building).
- Evidence mapping and review gates baked in (traceability without last‑minute firefighting).
- Private detail sharing for sensitive materials (minimum necessary, private agreement + scope + selective sharing).
Public artifacts
Public downloads include checksums and integrity manifests for independent verification.
Evidence‑ready delivery
Versioned outputs, change logs, and review gates—built for audit narratives and handovers.
Scope control
Sensitive implementation detail is shared privately: minimum necessary, scoped, and selective.
Founder
- Founder-led execution with audit-grade delivery as the default.
- Public frameworks and artifacts; implementation packs are shared privately.
- Clear scope, controlled change, and defensible handovers.
Standards & references
When we mention “audit-grade”, we mean traceable inputs, controlled outputs, and evidence mapped to official sources. See Standards & References and Audit‑grade.
FWL.ai is not an ISO 13485‑certified organization. Deliverables are aligned to ISO 13485 / ISO 14971 practices where applicable.
Next step
If you have a timeline and constraints, use Contact options to pick the shortest route.
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