Regulatory laws change.
Your products must keep up.
We monitor regulatory authorities across jurisdictions — FDA, EUR-Lex, ISO, BSI, and more. When a law, standard, or guideline changes, we extract the requirements that affect your product and deliver them as clear signals.
No more manually reading gazettes. No more missing transition deadlines. Each signal comes with a tamper-proof audit trail — so you can prove compliance, not just claim it.
Why This Matters
Regulatory intelligence, explained in plain English
The problem it solves
Companies that sell medical devices, industrial machinery, AI systems, or connected products must comply with dozens of regulations — EU AI Act, FDA rules, ISO standards, national laws. These regulations change constantly. Most teams track them manually: someone reads the Federal Gazette, forwards an email, updates a spreadsheet. This is slow, error-prone, and creates no auditable evidence that you even knew about a change.
What it does
The platform automatically reads regulatory sources (laws passed, standards updated, guidance documents published) and uses natural language processing to extract the specific requirements buried inside them. It turns a 200-page regulation into structured, machine-readable signals — each with source reference, affected categories, deadlines, and confidence score. Think of it as a "regulatory RSS feed" but much smarter: it understands what the text means, not just that something was published.
The audit trail
Every extracted signal is chained into a cryptographic hash trail. When a regulator asks "did you know about this change and when?", you can prove it with an immutable record — from the moment the regulation was published to the moment your team acted on it. This is not a spreadsheet you edit by hand; it's evidence that holds up in an audit.
Who it's for
Quality managers, regulatory affairs teams, and compliance officers at companies selling into regulated markets — especially MedTech (FDA, MDR, IVDR), machinery manufacturing (CE marking, MaschinenVO), AI/ML products (EU AI Act), and connected/IoT devices (Cyber Resilience Act, NIS2). If your product needs a CE mark, FDA clearance, or ISO certification, this is built for you.
How a Signal Gets to You
From regulatory publication to your compliance dashboard in four steps.
Source Monitoring
We continuously crawl EUR-Lex, FDA.gov, ISO.org, national gazettes, and other regulatory sources for new publications and amendments.
NLP Extraction
Natural language processing reads the full text, identifies compliance-relevant requirements, deadlines, scope changes, and classification criteria.
Signal Structuring
Extracted data becomes a structured signal: title, source reference, affected categories, region, type, deadline, and confidence score.
Crypto Audit Trail
Each signal is hashed and chained into an immutable audit trail. You get proof of when each regulation was published, detected, and when you acted.
Regulatory Signals
Live signals extracted from monitored regulatory sources
Loading signals...
Built for AI Agents, Not Just Humans
The platform exposes 7 dedicated MCP tools and REST endpoints so AI agents (Claude, GPT, custom copilots) can search signals, scan products for applicable regulations, and generate compliance impact reports — all without human-in-the-loop for the discovery phase.
⚡ Example: Agent Compliance Workflow
regulatory-scan — AI reads your product description and identifies applicable regulations compliance-impact — Agent drills into each regulation: requirements, artifacts, deadlines signal-changes — Daily/weekly check for new regulations affecting your product signal-digest — Concise briefing: active regs, deadlines, recommended actions MCP Tools (25 total: 14 lead + 11 signal)
search-signalsSearch signals by text, region, category, type, sector, or status
signal-detailsGet complete signal record by ID — description, deadline, affected sectors, source URL
regulatory-scanPrimary discovery tool: describe a product and get all applicable regulations ranked by impact
compliance-impactDeep-dive into a specific regulation: requirements, artifacts needed, urgency, effort estimate, next steps
signal-changesGet recently published/changed signals since a date — for daily monitoring
signal-digestConcise briefing: active regs by category/region, upcoming deadlines, prioritized recommendations
affected-regulationsList applicable regulations given structured sector/region filters (alternative to free-text scan)
submit-signal-reviewAgent → human handoff: propose a compliance action on a signal for human review
list-signal-reviewsView the human-in-the-loop review queue with pending counts by priority
decide-signal-reviewHuman decision endpoint: approve, reject, or request-more-info on agent proposals
trigger-signal-ingestSeed/refresh the signal database from the curated dataset (idempotent)
REST API Endpoints
| Endpoint | Method | Description |
|---|---|---|
| /api/demo/signals | GET | Search & filter regulatory signals |
| /api/demo/signals/:id | GET | Get signal by ID |
| /api/demo/signal-stats | GET | Aggregate statistics |
| /api/demo/signal-digest | GET | Concise regulatory activity digest |
| /api/demo/compliance-scan | POST | Scan product for applicable regulations |
| /api/mcp/sse | GET | MCP SSE transport (25 tools) |
🔌 Connect Your Agent
Any MCP-compatible client (Claude Desktop, Cursor, custom copilots) can connect to the signal tools via SSE transport. The SKILL.md descriptor at /.well-known/skills/index.json enables automatic tool discovery.
GET /api/mcp/sseX-Service-Token HMAC 14 lead + 11 signal = 25Agents Propose. Humans Decide.
The platform doesn't just alert you — it runs a full agentic loop: the signal monitor agent scans regulatory changes, computes impact on your products, and submits proposed compliance actions into a review queue. You (the human) approve, reject, or ask for more info. Every decision is logged for the audit trail.
Monitor
Signal monitor scans new regulatory changes since last run
Assess
Impact computed against your product description (critical → low)
Propose
submit-signal-review creates the proposal with artifacts & deadline
Decide
decide-signal-review — approve, reject, or request more info
Audit
Full loop logged: who proposed, who decided, when, and why
📋 Review Queue API
🔄 Agent Loop
The signal-monitor domain agent runs on a schedule, uses signal-changes + compliance-impact, submits proposals via submit-signal-review, and notifies you via in-app/email/push when a human decision is needed.
Stop chasing regulations.
Let them come to you.
We turn days of manual regulatory tracking into minutes of structured, auditable intelligence. Connect your quality management system and see signals flow in automatically.