01
Secure intake and normalized project record
Operating capabilityEverything you submit becomes one structured project file.
Files are scanned, sandboxed during parsing, hashed, and receipted, then extracted once into a normalized record of product identity, intended use, population, users, mechanism, jurisdiction, stage, and decision sought. High-impact facts are confirmed by your team before anything depends on them.
02
MedTech ontology
Operating capabilityA shared vocabulary so terms mean the same thing everywhere.
Products, claims, indications, populations, pathways, standards, processes, evidence types, and partner capabilities are represented in one controlled model, so a claim written in an intake form and a claim cited in a regulatory scenario refer to the same object.
03
Evidence and provenance graph
Operating capabilityEvery claim points back to the exact source that produced it.
Extracted facts, cited literature, standards, precedents, and internal data are stored as linked nodes carrying authority, directness, integrity, independence, recency, and applicability, with the source span retained for inspection.
04
Retrieval-augmented intelligence
Operating capabilityAnalysis is grounded in retrieved sources, not model recall.
Analysis draws on retrieved project and reference material under an explicit source policy. Statements that cannot be grounded in a retrievable source are not produced as conclusions.
05
Specialized agent orchestration
Operating capabilityNarrow software roles, each with strict limits.
Each agent is a bounded role with a source policy, tool budget, output schema, confidence method, prohibited actions, and escalation path. Agents produce proposals; they never hold authority.
06
Hypercube multidimensional reasoning
Operating capabilityProject state is addressable by domain, jurisdiction, stage, and scenario.
State is held as addressable cells across project, domain, jurisdiction, stage, scenario, evidence state, and version, so a regulatory conclusion in one jurisdiction never silently overwrites another.
07
Versioned policy packs
Operating capabilityThe rules applied to your project are pinned and dated.
Classification logic, evidence thresholds, gate criteria, and disclosure rules are versioned artifacts. A decision records the policy version that produced it, so a later rule change is visible as a change rather than a silent rewrite.
08
Contradiction detection
Operating capabilityConflicts between your own documents are surfaced, not averaged.
Conflicting intended-use statements, incompatible claims, and disagreeing sources are raised as explicit contradictions attached to the affected decisions, and they block confident conclusions until resolved.
09
Confidence and uncertainty
Operating capabilityRanges and assumptions instead of false precision.
Conclusions carry a confidence method and an uncertainty statement; cost and schedule are expressed as P50 and P80 ranges with assumptions and sensitivity drivers, and numeric readiness is suppressed when evidence completeness is too low to be meaningful.
10
Decision ledger
Operating capabilityAn append-only record of what was decided and why.
Every decision object records alternatives, evidence, contradictions, assumptions, confidence, safety and regulatory implications, approver, review date, cost and timeline range, next action, and eventually the observed outcome.
11
Human authorization
Operating capabilityPeople sign; software proposes.
Binding conclusions route to reviewers with the required authority. Approval, conditions, dissent, override rationale, escalation, and signature are first-class records, and unauthorized state transitions fail closed.