Grounded in sources
Every output links back to the regulatory passage it rests on, marked with a citation. That is what stands up in an audit.
About us
We put compliance on a foundation of evidence.
For medical device manufacturers, we produce MDR technical documentation grounded in the regulations in force and traceable line by line. The AI works only from loaded sources; no claim is produced without one.
Traceable
From the GSPR map to the Word document, every row is traceable. Traceability is the core demand of the MDR.
Honest
With no source the AI does not invent — it says it could not find one. We never present an unfinished module as finished.
What we do today
We began our journey with the MDR Annex II Section 4 module — General Safety and Performance Requirements (GSPR). On the same source pool we built regulatory analysis, review and chat; we keep growing the ecosystem with the other parts of the technical file.
