ON-PREM AI · MEDICAL DEVICES & PHARMA
Compliance AI that runs on your servers. And cites real evidence — every time.
MedComplyAI is an on-premise regulatory compliance platform for medical device and pharmaceutical companies. Gap analysis, submission readiness, and audit-grade reporting across MDR, 510(k), ISO 14971, ISO 13485, CTD, and drug labeling — powered by open-source models and a grounding validator that blocks any output the AI can't prove.
MedComplyAI
(in your perimeter)
Data never leaves your environment.
BUILT FOR REGULATED SUBMISSIONS
Most compliance tooling is either too rigid or too unreliable.
Static checklists are accurate but brutally slow. They don't scale across products, regions, or submission cycles.
Cloud-hosted LLM summarizers are fast but fundamentally unauditable. The model hallucinates, citations are fabricated, and you can't explain why a requirement is met in a way that survives an FDA inspection.
MedComplyAI is built on a third model: deterministic, evidence-indexed AI — designed from the evidence up.
Local-first by design
Runs on open-source models inside your perimeter. Qwen 2.5 7B for inference, GTE-Qwen2 1.5B for embeddings — all served via Ollama. Air-gapped deployment supported.
Read moreDeterministic, not decorative
Pass/fail coverage decisions for ISO 14971 and MDR Annex I are made by rule-based evaluators — not by an LLM. The model explains. Auditors trust the rules.
Read moreGlass Box AI
Every AI output is grounding-validated before it reaches you. Outputs that cite fabricated evidence IDs are blocked, not flagged. Hallucination becomes a 4xx error, not a finding.
Read moreEvery run is an immutable snapshot. Replayable. Comparable across versions. Exportable for audit.
Ready to see it run on your stack?
30-minute demo. We can walk through the architecture before a single document is shared.
Book a Demo