Limited access

Regulatory intelligence with traceable references

A structured query interface across EU MDR, ISO, IEC, ASTM, and MDCG guidance documents. Every answer is grounded in retrieved evidence, scored for confidence, and linked to its source — down to the article, section, and page.

From question to referenced answer

Global Intelligence
Chat History +
🗨 ISO 15223-1 applicab...
🗨 GSPR 10.4 chemical...
🗨 Biocompatibility end...
References and Warnings
High Confidence
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Standard Detection
The system scans your question for explicit standard references (e.g. "ISO 14971") and implicit domain signals (e.g. "risk management" maps to ISO 14971, "biocompatibility" maps to ISO 10993). Explicit standards receive a strong priority boost.
Adaptive Retrieval
Search depth adjusts to question complexity — narrower for single-standard queries, wider for multi-standard questions. Retrieved content is filtered by regulatory domain and re-evaluated for relevance, capturing meaning nuances that keyword matching alone would miss.
Diversity Guarantee
If a standard explicitly referenced in the question is missing from initial results, a targeted follow-up search is performed. Every named standard gets representation in the final evidence set — provided relevant content exists in the database.
Grounded Response
The language model generates a response using only the retrieved evidence. It can connect information across sources and explain inter-standard relationships — but it cannot fabricate article numbers, invent requirements, or reference standards not in the database.
Leakage Detection
After generation, the response is scanned for references to standards not present in the evidence database. Any detected leakage is flagged with a warning — signaling the user to verify independently.

What separates this from a general AI search

Domain-Aware Retrieval

The system doesn't just find similar text — it understands regulatory domains. 13 domain categories (risk, sterilization, biocompatibility, software, clinical, etc.) drive retrieval filtering. A question from a manufacturer perspective doesn't surface notified body-specific guidance.

Closed Evidence System

Responses are generated exclusively from the verified standards database — ensuring every regulatory claim is traceable to a documented source. The model operates within a closed evidence boundary for all normative content.

Post-Generation Leakage Detection

After every response, an automated scan checks whether the model referenced any standard not present in the evidence database. Detected leakage is flagged with a visible warning — the user knows exactly which claims to verify independently.

Explicit vs Implicit Standard Handling

Standards mentioned by name receive strong retrieval priority and guaranteed representation. Implied standards (detected via keyword-domain mapping) receive a softer boost and compete on relevance — ensuring the answer stays focused on what you actually asked.

Independent Query Evaluation

Each question receives a clean, standalone evaluation — grounded solely in the evidence retrieved for that specific query. This ensures consistent, reproducible answers regardless of what was asked before.

Competence Over Completeness

The system prioritizes relevance and accuracy over exhaustive coverage — every claim it presents is grounded, referenced, and scored for confidence. Depth on what matters, rather than breadth across everything.

Global Intelligence is a guidance and competence layer — technical documentation generation belongs to TD Workspace, conformity assessment belongs to Simulation.

Every answer carries its confidence level

High

Direct Match

The referenced standards were found in the database and retrieved evidence directly addresses the question. Source references are specific and traceable.

Medium

Domain Match

No direct standard match, but relevant evidence was found within the applicable regulatory domain. The answer is grounded but may require additional verification.

Low

Limited Evidence

Minimal matching evidence was retrieved, or the requested standard is not present in the database. The response may rely on general regulatory knowledge and should be independently verified.

Structured access to the regulatory landscape

EU MDR 2017/745
Full regulation text — Articles 1–120, Annexes I–XVII including GSPR requirements
ISO Standards
QMS, risk management, biocompatibility, clinical investigation, sterilization, packaging, labelling
IEC Standards
Usability engineering, software lifecycle, electrical safety and EMC
ASTM Standards
Accelerated aging, transport simulation, material and performance testing
MDCG Guidance
Clinical evaluation, classification, and implementation guidance documents
526
Regulatory References
100+
Standards Mapped
13
Domain Categories
7
Pipeline Steps

"A structured query interface across the standards — not a regulatory chatbot."

Every reference sourced. Every confidence level visible. Every limitation stated.

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