Auddax ClearanceOS

A guided clearance-readiness package for regulated medical AI.

ClearanceOS is the regulatory readiness workspace for medical AI teams, turning product development into a continuous evidence-generation process for FDA clearance and other regulated pathways.

It helps companies move from prototype to submission-ready product by organizing intended use, model boundaries, deterministic clinical logic, validation evidence, risk controls, change plans, and replayable clinical traces in one governed workspace.

Request technical brief View workspace
clearance workspace evidence linked 
$ auddax clearance init product.yml --pathway fda-presub
workspace: ClearanceOS
product: cardiac_triage_assistant
pathway: FDA pre-submission

living_evidence_file:
  intended_use: linked
  model_roles: 4 documented
  protocol_logic: deterministic
  validation_plan: in_progress
  risk_controls: 28 mapped
  change_plan: draft
  trace_samples: 42 attached

readiness:
  design_history: organized
  evidence_gaps: 9 open
  counsel_review: required
Regulated workflow

Build inside the evidence file from the beginning.

Instead of assembling documentation manually at the end, teams build inside a regulated workflow from the beginning. Every protocol, model role, prompt, dataset, release, safety test, clinical trace, and output claim is linked to a living evidence file.

By the time a company is preparing for pre-submission, 510(k), De Novo, or another pathway, ClearanceOS has already organized the design history, validation record, risk controls, and change plan behind the product.

Product work Evidence created Review surface
Define intended use Claims, users, population, setting, exclusions Root product contract
Attach model roles Role boundaries, tests, schemas, blocked claims Model role dossier
Compile protocols Clinical rationale, deterministic logic, release diffs Protocol evidence file
Validate release Safety gates, red flags, subgroups, trace samples Validation summary
Plan changes Allowed changes, required evidence, review triggers PCCP / change plan
What ClearanceOS Includes

A shared workspace for product, engineering, clinical, quality, and regulatory teams.

ClearanceOS turns the core artifacts behind a regulated medical AI product into structured, linked work. Each module keeps the product claim, model behavior, deterministic logic, data permissions, privacy controls, safety evidence, and release history connected as the system evolves.

  1. 01 Intended Use Builder
    Defines the claim, user, patient population, care setting, inputs, outputs, exclusions, and clinical role.
  2. 02 Regulatory Pathway Mapper
    Maps the product toward likely categories such as non-device CDS, device CDS, SaMD, AI-enabled software, 510(k), or De Novo.
  3. 03 Design History File Automation
    Organizes requirements, architecture, software specifications, verification tests, validation results, and traceability matrices.
  4. 04 Model Role Dossier
    Documents what each LLM may do, how it is tested, where it is blocked, what data it sees, and what schemas it emits.
  5. 05 Clinical Evidence Planner
    Defines scientific basis, protocol rationale, GitMed release diffs, SignalOS Vault manifests, gold-standard cases, subgroup analysis, red-flag performance, and validation needs.
  6. 06 Risk Control Workspace
    Links hazards to controls, tests, labeling, and monitoring for model overreach, data-quality failure, consent mismatch, privacy-risk failure, missed emergencies, and misuse.
  7. 07 PCCP / Change Plan Compiler
    Defines allowed future changes, required validation, and when model, prompt, protocol, mapping, or composer changes exceed the approved boundary.
  8. 08 Submission Evidence Exporter
    Packages intended use, architecture, validation summaries, trace samples, cybersecurity materials, boundaries, controls, and release history.
  9. 09 Human Factors And Labeling Workspace
    Documents users, environments, interactions, transparency language, warnings, limitations, and use-related risk controls.
  10. 10 Post-Market Monitoring Plan
    Defines monitoring for drift, overrides, complaints, incidents, model failures, out-of-scope cases, subgroup degradation, and cybersecurity issues.
Evidence system of record

Capture the actual clinical AI evidence, not just compliance attestations.

Traditional compliance tools track policies and attestations. ClearanceOS captures the product evidence behind regulated clinical AI: model-role tests, protocol diffs, replayable traces, safety gates, claim verification, sensitive-data manifests, consent checks, privacy-risk gates, change plans, incident records, and release history.

When teams use GitMed and SignalOS, ClearanceOS links directly to the protocol and data evidence they produce: source anchors, behavior diffs, sparring results, signal permissions, Vault manifests, consent scope checks, privacy-risk decisions, exclusion decisions, clinical findings, reviewer signoffs, registry records, and release artifacts.

  • Living file Artifacts update as product decisions, model roles, protocols, validation suites, and releases change.
  • Traceable Requirements link to controls, tests, validation results, traces, releases, and open evidence gaps.
  • Exportable Teams can generate organized packets for regulatory advisors, quality teams, and internal review.
evidence export review packet 
$ auddax clearance export candidate-2026.05.07 --packet regulatory-review
export: clearanceos/candidate-2026.05.07/

included:
  intended_use.md
  software_architecture.md
  model_role_boundaries.yaml
  protocol_evidence/
  signal_admissibility_summary.md
  vault_manifest_index.yaml
  consent_scope_report.md
  privacy_gate_results.json
  custody_boundary_attestation.md
  validation_summary.pdf
  risk_controls.csv
  cybersecurity_materials.md
  human_factors_labeling.md
  change_plan.md
  trace_samples/
  release_history.json

open_items:
  - counsel_review
  - clinical_validation_protocol
  - post_market_monitoring_signoff

The result is a clearer path from impressive demo to governed medical device workflow, with the evidence trail assembled as the product is built.

PCCP / Change Plan

Planned change strategy becomes enforceable release logic.

ClearanceOS defines which future changes are allowed, what validation they require, and when a change exceeds the approved boundary. Model upgrades, prompt changes, protocol edits, signal mappings, Vault manifests, privacy-risk gates, and output-composer changes flow through the same evidence-backed process.

Change Evidence Decision
Model upgrade Role regression, subgroup analysis, claim verification Inside boundary or higher review
Protocol edit Source rationale, behavior diff, safety gate replay Clinical signoff required
Wearable mapping Admissibility thresholds, source trust, quality tests Workflow-specific approval
Output composer Labeling, claim boundaries, human factors review Release packet update
Clearance-readiness workspace

ClearanceOS helps teams build, validate, and defend a medical AI product.

ClearanceOS does not replace regulatory counsel. It gives product, engineering, clinical, quality, and regulatory teams the shared system of record they need to prepare for review.

Request technical brief View Auddax platform

Auddax ClearanceOS

Guided clearance-readiness for regulated medical AI teams.

brief@auddax.ai