Compliant AI for medical device and pharmaceutical R&D
Regulated environments under FDA QMSR, 21 CFR Part 11, and ISO 13485 demand full provenance tracking, determinism, and audit readiness. Morden’s architecture maps directly to these requirements — not as an afterthought, but as the design basis.
Regulatory compliance meets AI assistance
Medical device and pharmaceutical R&D generates complex documentation sets: clinical trial data, FDA 510(k) predicates, biocompatibility test results, regulatory standards, and design history files. Researchers need to cross-reference across these documents under strict data handling rules where cloud processing creates compliance risk. Generic RAG tools can search the text, but they cannot capture the structural relationships between test results, regulatory requirements, and design specifications — the connections that regulatory submissions depend on.
Example: 510(k) predicate analysis
A regulatory affairs specialist is preparing a 510(k) submission for a new medical device. Their corpus includes predicate device documentation, biocompatibility test results, ISO 13485 procedures, clinical evaluation reports, and FDA guidance documents. Morden’s knowledge graph maps the relationships between the device’s claimed equivalence, the predicate’s specifications, and the applicable regulatory requirements. The specialist can ask ‘What biocompatibility tests are required for this material contact classification that were not performed on the predicate device?’ and get a cited, traceable answer.
Where the market stands
Production-grade local RAG solutions for regulated environments are emerging but lack knowledge graph capabilities and source quality differentiation. Enterprise platforms offer compliance features but require cloud deployment. Morden provides the compliance-ready architecture — offline, auditable, with full provenance — at a scale accessible to R&D teams rather than enterprise IT departments.
Want to see Morden work with medical device and pharmaceutical documentation? Get in touch at hello@nichesoft.co.uk.