AI-Powered Medical Device Compliance

AI That Cites, Never Fabricates

UCOS connects every AI response to a curated regulatory knowledge graph — delivering citation-backed, auditor-ready outputs for medical device compliance.

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EU MDR
Regulation
FDA QSR
Regulation
ISO 13485
Standard
MDSAP
Framework
How It Works

The GGG Pipeline

Every AI response passes through five stages — from query to citation-backed answer.

STEP 01

Query Analysis

User question parsed for regulatory intent, device class, and applicable standards.

STEP 02

Graph Traversal

Knowledge graph queried via parent-child-related atom relationships.

STEP 03

Context Assembly

Relevant atoms ranked, filtered by applicability, and assembled as grounded context.

STEP 04

Grounded Generation

AI generates response strictly from assembled atoms — no parametric knowledge.

STEP 05

Citation & Verify

Every claim mapped back to source atoms. Ungrounded statements removed.

Command Center

Your Compliance Health Score, at a glance.

Dynamic rings and action cards. See instantly how audit-ready you are for each market.

UCOSUCOS
EU MDR
87%
Audit-Ready
FDA 510(k)
72%
Audit-Ready
Health Canada
54%
Audit-Ready
⚡ Smart Gaps — Action Cards
FDA 21 CFR 803 Adverse Event reporting timeline must be added to MDR complaint procedure.
MDSAP_CH5_T3
IFU Rev.3 Pediatric use contradiction detected with Risk Analysis.
ISO_14971_D.2
Core Capabilities

Features Built for Regulatory Confidence

Every feature designed with one goal: AI you can submit to auditors.

🔗

Knowledge Graph Engine

Regulatory atoms with parent-child-sibling relationships across ISO 13485, ISO 14971, EU MDR, FDA QSR, MDCG, IMDRF.

Core Engine
📎

Citation-Backed Outputs

Every AI response links to specific standard sections, clause numbers, and atom IDs. Hover to preview, click to trace.

Audit-Ready
🛡️

Hallucination Defense

Multi-layer defense: system constraints, graph grounding, confidence scoring, contradiction detection, kill switch, human review.

Safety-Critical
✍️

Evidence-Backed Drafting

Draft SOPs, risk analyses, clinical evaluations — every paragraph pre-grounded in applicable regulatory requirements.

AI-Powered
🔍

Cross-Document Brain

Detects contradictions between your documents and regulatory requirements in real-time. Change one clause — see what else needs updating.

Multi-Doc
📊

Gap Analysis Engine

Upload your QMS or technical file. Maps documents against the knowledge graph and surfaces what's missing.

Compliance
🤖

Embedded Auditor Mode

AI reviews from an auditor's perspective — using real FDA 483 findings and Warning Letter patterns as benchmarks.

Auditor Sim
⚡

Change Impact Analysis

Modify a design input or process — instantly predicts which documents and submissions are affected.

Risk Prevention
🌐

Multi-Framework Coverage

One platform covers FDA QSR, EU MDR, ISO 13485, ISO 14971, IEC 62304, MDSAP — cross-mapped relationships.

Global
🧬

Living Documentation

Documents connected to the knowledge graph. When a standard updates, all affected documents are flagged automatically.

Always Current
💬

UCOS Advisor Chat

Multi-dimensional response framework with severity classification, applicable standards, and confidence scores.

AI Framework
🔐

ALCOA+ Audit Trail

Every interaction recorded with hash-chain validation. Attributable, Legible, Contemporaneous, Original, Accurate.

Data Integrity
Trust Architecture

Hallucination Defense System

In medical device compliance, "almost right" is never acceptable.

L1
System Prompt Constraints
Regulatory domain boundaries enforced at model level
Automatic
L2
Graph Grounding
Responses generated only from retrieved knowledge atoms
Automatic
L3
Confidence Scoring
Each claim scored for grounding strength — low scores flagged
Automatic
L4
Contradiction Detection
Cross-reference output against knowledge graph for conflicts
Automatic
L5
Kill Switch
Automatic suppression of ungrounded or uncertain statements
Active Defense
L6
Human-in-the-Loop Review
QA/RA professionals validate critical outputs before use
Manual Gate
L7
ALCOA+ Audit Trail
Complete, immutable record of every AI decision and source
Always On

Simple, transparent pricing

Start free, scale as you grow

Free Trial

€0/mo

14 days, no credit card

  • 1 product
  • 2 users
  • Device classification
  • Basic gap assessment
  • 5 AI chats/day
  • Export
  • Document import
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Starter

€599/mo

For small teams getting started

  • 1 product
  • Up to 5 users
  • 50 GB storage
  • 100 exports/month
  • 50 AI chats/day
  • Document import (50/month)
  • EU market
  • GGG citations
  • Gap analysis
  • Basic audit trail
  • Email support (48h SLA)
  • Cross-doc contradiction scan
  • Embedded auditor critical feed
  • Multi-market
Start Free Trial
Most Popular

Professional

€1,799/mo

For growing companies

  • 5 products
  • Up to 25 users
  • 500 GB storage
  • Unlimited exports
  • Unlimited AI chats
  • Unlimited document import
  • EU + US markets
  • Full GGG suite
  • Cross-doc contradiction scan
  • Embedded auditor critical feed
  • Real-time gap analysis
  • Compliance score per market
  • ALCOA+ full audit trail
  • Obsolete impact analysis
  • Auto-training generation
  • Change impact analysis
  • Priority support (24h SLA)
  • Custom integrations
  • Dedicated CSM
  • On-premise option
Start Free Trial

Enterprise

Custom

Starting from €3,000/month

  • Unlimited products
  • Unlimited users
  • 2 TB+ storage
  • Multi-market (EU, US, CA, JP, KR)
  • Dedicated support (4h SLA)
  • Dedicated CSM
  • Custom integrations (SAP, SharePoint, Jira)
  • SSO (SAML/OIDC)
  • Custom AI training on company data
  • API access
  • SLA guarantee (99.9%)
  • Onboarding package (20h)
  • Quarterly business reviews
  • On-premise option available
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FAQ

Everything You Need to Know

Questions regulatory teams ask before adopting AI in their QMS workflow.

GGG is UCOS's AI architecture that constrains all language model outputs to a curated regulatory knowledge graph. Unlike generic AI, GGG only produces statements traceable to specific, verified regulatory atoms extracted from standards like ISO 13485, EU MDR, FDA QSR, and more.
Through a multi-layer defense: system prompt constraints, graph grounding, confidence scoring, contradiction detection, kill switch, human-in-the-loop review, and ALCOA+ audit trail. If it can't ground a claim, it says "I don't know" — never fabricates.
ISO 13485, ISO 14971, EU MDR 2017/745, FDA 21 CFR 820, IEC 62304, IEC 60601, IEC 62366, MDCG guidance, FDA 483 observations, IMDRF guidance, MDSAP requirements, and more. The graph is continuously enriched.
Yes. Evidence-Backed Drafting generates SOPs, risk analyses, clinical evaluations, GSPR checklists, PMCF plans — every paragraph grounded in applicable requirements. AI accelerates, humans validate.
It reviews your documents against real-world audit intelligence: FDA 483 patterns, Warning Letter themes, MDCG deficiency findings, and NB best practices. Identifies gaps, scores severity, and suggests corrective actions.
Absolutely. Covers IEC 62304, IMDRF SaMD classification, FDA cybersecurity guidance, MDCG 2019-11, MDCG 2021-24 Rule 11, and AI/ML-specific requirements with automatic applicability filtering.
Multi-tenant architecture with Row-Level Security, ALCOA+ audit trails with hash-chain validation. Your documents never leave your tenant boundary. No customer data is used to train AI models.
Yes. We offer a guided pilot — we onboard your team, import your QMS documentation, and run a Gap Analysis against the full knowledge graph. Contact us to schedule.

Ready to Eliminate Regulatory Guesswork?

Join medical device teams who trust UCOS for audit-ready compliance.

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