The Regulatory Engine for
EU MDR 2017/745
Identify documentation gaps before they become findings.
A structured regulatory assessment of your full technical file. Finding-level results in hours.
What the current workflow gets wrong.
Three structural gaps in how technical documentation is prepared and assessed under the MDR.
Checklists don't build compliance
Spreadsheets flag checkboxes — not whether the evidence actually addresses the specific sub-requirements of Annex I or the structure expected under Annex II/III.
Reviews take months, not days
Multiple rounds of queries and responses — months of back-and-forth before a single finding is resolved.
References are scattered, not structured
MDR text in one tab, MDCG guidance in another, harmonized standards somewhere else. No cross-references, no traceability between them.
Three modules. One regulatory workflow.
Each module covers a distinct phase of the conformity assessment lifecycle. Simulation is available today; the other two are in limited access.
Simulation Module
A structured conformity assessment that processes a technical file through 13 evaluation blocks, with finding-level outputs mapped to specific MDR requirements and a traceable regulatory reference behind every question.
TD Workspace Module
End-to-end technical documentation generation for EU MDR 2017/745. Each section is drafted with device-specific context, mapped to applicable requirements and a 14-bucket document structure, with every claim classified and traceable.
See how it worksGlobal Intelligence Module
A structured query interface across EU MDR, ISO/IEC, ASTM, and MDCG guidance. Responses are citation-backed with traceable references down to the article, section, and page — with confidence scoring per answer.
See how it worksUnderstand. Build. Verify.
Three phases of the regulatory lifecycle, each supported by a dedicated module.
Understand
The Global Intelligence module provides structured access to MDR text, harmonized standards, and MDCG guidance — with traceable, citation-backed references per query.
Build
TD Workspace generates technical documentation section by section, using device-specific context and regulatory mapping to produce structured, requirement-aligned drafts.
Verify
The Simulation module evaluates the technical file through structured assessment blocks, producing finding-level feedback mapped to specific MDR requirements.
Why the output can be trusted.
Two foundations behind the platform — how the system is engineered, and how your data is handled.
Engineering
Built with the discipline of a regulated development process, the system is constrained to a closed evidence base and cannot approve its own work.
Security
Hosted in the EU and built around GDPR principles, with access controls and encryption applied throughout.
A single engine that turns regulatory intelligence into documentation and audits technical files against EU MDR 2017/745.
A structural response to how technical documentation is prepared and reviewed.