The Regulatory Intelligence Protocol

Compliance
is now computable

Thinkerton encodes every regulation, standard, and guidance as a queryable knowledge graph. AI agents don't guess at compliance they prove it.

8,400+
Encoded Obligations
12
Jurisdictions
30s
PSUR Generation
100%
Audit Traceable
01 -- The Paradigm

Regulations don't change. The way we use them hasn't changed in 30 years.

Every quality professional in MedTech and Pharma does the same thing: reads a regulation, interprets it, maps it to evidence, and documents the decision. Thinkerton does this computationally -- with cryptographic proof.

Before Thinkerton
  • 4-12 weeks per PSUR, manually coordinating across 5+ departments
  • Regulatory knowledge locked in senior employees' heads
  • Audit preparation is 80% document archaeology
  • Each new regulation triggers months of gap analysis
  • Compliance is claimed, never proven
With Thinkerton
  • 30-second PSUR generation with full evidence traceability
  • Regulatory knowledge encoded as a queryable graph -- immune to turnover
  • Every decision SHA-256 hashed -- audit-ready by default
  • New regulation? Import obligations, re-validate in minutes
  • Compliance is computed, verified, and cryptographically sealed
02 -- GRKB Live

Watch the knowledge graph think

Select a process. Watch obligations activate, agents spawn, evidence flow, and validation gates fire -- all governed by the GRKB.

GRKB
Art. 86 PSUR
EU_MDR_ART86
MDCG 2022-21
MDCG_2022_21
Art. 87 Vigilance
EU_MDR_ART87
Annex III PMS
ANNEX_III_PMS
Benefit-Risk
SLOT
Sales Analysis
SLOT
Incident Summary
SLOT
PMCF Results
SLOT
BR
BenefitRisk Agent
SA
Sales Agent
VA
Vigilance Agent
PM
PMCF Agent
risk_data
ATOM
sales_volume
ATOM
incident_record
ATOM
pmcf_result
ATOM
VALIDATION GATE
awaiting
0
Obligations
0
Agents
0
Evidence
--
Compliance
GRKB initializedISO 13485 loadedEU MDR 2017/745 loadedAgent pool readyEvidence registry connectedHash chain: 0x4a8f...c3d1
GRKB initializedISO 13485 loadedEU MDR 2017/745 loadedAgent pool readyEvidence registry connectedHash chain: 0x4a8f...c3d1
03 -- Coverage

One graph. Every process.

The GRKB encodes obligations across the entire quality system. Same infrastructure, same audit trail, same deterministic validation.

PSUR Generation
Periodic Safety Update Reports with full MDCG 2022-21 compliance, MedDRA coding, and trend analysis.
EU MDR Art. 86 | MDCG 2022-21 | Annex I-IV
Clinical Evaluation
CER generation with systematic literature review, equivalence analysis, and benefit-risk determination.
EU MDR Art. 61 | Annex XIV | MEDDEV 2.7/1 Rev 4
CAPA Management
Root cause investigation, action planning, effectiveness verification -- all obligation-mapped and traceable.
ISO 13485 SS8.5.2/8.5.3 | 21 CFR 820.90
Risk Management
ISO 14971 lifecycle -- hazard identification through residual risk acceptance with evidence-backed decisions.
ISO 14971:2019 | EU MDR Annex I Ch. I
Vigilance & Field Actions
Incident reporting, FSCA management, and regulatory authority notification with automated timeline tracking.
EU MDR Art. 87-92 | 21 CFR 803 | MIR
Regulatory Submissions
510(k), PMA supplements, Technical Documentation -- structured, validated, submission-ready.
21 CFR 807/814 | EU MDR Annex II/III
04 -- Architecture

The GRKB is not a database.
It's a protocol.

Any AI agent, any framework, any vendor -- queries the GRKB, operates under regulatory constraints, and produces auditable output.

Regulation Source
Obligation Parser
GRKB Knowledge Graph
Inference API
AI Agents
Validation Gate
Audit Trace

Ready to make compliance
computable?

We're working with a small number of forward-thinking MedTech and Pharma companies. Request early access.