What it is
Most of what we do carries over directly into regulated environments. What changes is the standard of proof: the document does not just have to be right, it has to demonstrate that it is right to an auditor, a regulator, or a review board that arrives skeptical.
We've built systems for environments where getting it wrong has real consequences — healthcare, nuclear energy, export-controlled work. That discipline shapes how we structure traceability, handle sensitive data, and design the audit trail from the first artifact, not bolted on at the end.
What you get
- HIPAA architecture: PHI handling, de-identification, BAA structuring
- Nuclear regulatory: 10 CFR 73.54 airgap, NRC cyber security, NQA-1
- FDA Software-as-a-Medical-Device boundary analysis
- ISO/IEC software-lifecycle artifacts (29148, 29119, 12207)
- Audit trail and explainability for regulated environments
How it works
We work the compliance frame into the deliverable from the start: the regulation or standard that governs it, the evidence it has to produce, and the form an auditor expects to see. That is cheaper and more defensible than retrofitting compliance onto work that was not built for it.
Across healthcare (HIPAA, PHI handling, de-identification, BAAs), nuclear (10 CFR 73.54 airgap, NRC cyber security, NQA-1), medical-device boundaries (FDA SaMD), and the ISO/IEC software lifecycle, the throughline is the same — artifacts that survive scrutiny because they were designed to.