Healthcare Regulatory · AI-Assisted Compliance
SAMD-OS.
Medical device teams can't ship because their regulatory artifacts are disconnected from their codebase. Design controls live in spreadsheets. Risk files reference code that's already changed. I built a regulatory operating system that generates IEC 62304 artifacts directly from the codebase and reviews them with domain-specialist agents.
01
Specialist Reviewers
5 domain-expert agents modeled on real practitioners. Each reviews against specific standards with structured verdicts: ACCEPTABLE, NEEDS REVISION, or NOT SUBMITTABLE. Regulatory, QA, safety, cybersecurity, and clinical neonatal SpO2.
02
Artifact Generators
Design controls, risk management, FHIR bundles, change impact analysis, design review packages. Output as XLSX, JSON, and Markdown. Each artifact traces back to source code and requirements — no manual reconciliation.
03
Gap Analysis
Reverse-engineer compliance from existing codebases. Three skills for teams that shipped before documenting: Code → SOUP Register, Code → Design Inputs, Code → Hazard Candidates. Produces audit-ready artifacts from code that already exists.
04
Clinical Pathway Spec
Evidence-based clinical device specification for sarcopenia resistance training with FHIR CarePlan integration. Grounded in 14 RCTs and 34 meta-analysis studies from ICFSR 2018 and EWGSOP2 consensus.
05
Validation
20/20 fixture format pass across all 5 agents. Structured verdicts validated against known-good and known-bad inputs. Full eval suite cost: ~$2.00.