A specialist services practice for defense, pharma, medtech, and rail. We combine fourteen years of systems engineering experience with modern AI tooling to produce the documentation your regulators and program offices demand.
Engineering teams spend months building requirements traceability matrices by hand, cross-referencing thousands of documents across DOORS, SharePoint, and legacy archives.
Every specification revision triggers cascading downstream work: impact assessment, test re-validation, RTM rebuild, and change board documentation. The cycle repeats with every design change.
Foundation models can draft documents but cannot certify compliance. Domain expertise, accountable human review, and regulatory pattern recognition are required to produce documentation regulators will accept.
We work from your existing documents. Send us a sanitized sample of your requirements, design, hazard, or test artifacts in whatever format your team uses today.
We organize your documentation into a structured representation, linking every requirement, design element, hazard, and test. This is the working model behind every deliverable we produce.
We apply the relevant regulatory framework to your documentation, drawing on the rule libraries we have codified from fourteen years of working in these domains. Every gap is flagged for review.
We produce your deliverables in the formats your reviewers expect. The founder reviews every output before delivery. You receive audit-ready artifacts with full source traceability.
A two-week engagement to assess your current documentation environment, identify the highest-leverage opportunities, and produce a tailored roadmap for further work. Best for organizations exploring whether AI-augmented documentation services fit their needs.
A four- to six-week engagement producing one complete deliverable end to end. Examples: a 510(k) Substantial Equivalence narrative, a CDR entry package, a complete RTM build from existing source documents. Best for organizations with a specific upcoming regulatory or program milestone.
A multi-deliverable engagement supporting a complete regulatory submission or program milestone. Includes multiple linked artifacts, revision cycles, and ongoing review support across a program phase. Best for organizations approaching a major milestone such as 510(k) submission or DoD Milestone B or C.
Trace AI is a specialist services practice, not an enterprise software product. We do not sell software licenses or platform subscriptions. We do not ask you to migrate off DOORS, Polarion, Jama, or any other tool you already use.
Our work is AI-augmented but human-accountable. We use Claude and other modern AI tools as force multipliers to accelerate the production of regulatory documentation. The founder reviews every deliverable before it reaches your team. You are paying for codified domain expertise and accountable quality, not for autonomous AI output.
Our differentiation is fourteen years of systems engineering experience across Navy submarine combat systems, locomotive controls, and Marine Corps acquisition, combined with a disciplined methodology and a deep regulatory rule library that we have built from real program work.
If you need a software platform with deterministic verification engines, we are not the right partner. If you need senior systems engineering judgment applied at speed to your regulatory documentation, we are exactly what you are looking for.
Trace AI is led by a senior systems engineer with fourteen years of experience across U.S. Navy submarine combat systems, U.S. Marine Corps acquisition, and locomotive controls. The founder's career spans requirements engineering, design verification, system safety, and regulatory documentation across defense, transportation, and adjacent regulated industries.
Trace AI applies that experience through a disciplined methodology and a regulatory rule library built from real program work. Modern AI tools accelerate the production of structured documentation. The founder reviews every deliverable before it reaches a client.
Full founder credentials shared on request following a discovery conversation.