From market authorization to market leader. Faster.
510(k), De Novo, PMA, EU MDR Technical File, Health Canada, TGA, PMDA: assembled directly from your DDF, risk file, and clinical evidence. LuminLogic IQ runs citation-first gap analysis against the framework you choose. No parallel binders, no manual TOC.
510(k), EU MDR, MDSAP assembled from the same evidence.
Submissions don't live in a separate Word folder. They are a view onto your DDF and quality records, with sections that recompose as evidence updates.
Section assembly
TOCs for 510(k), EU MDR, MDSAP jurisdictions, and more. Sections pull live evidence from your DDF and quality records.
Gap analysis
IQ surfaces missing evidence by jurisdiction and guidance, every flag cites the source and links to the record gap.
Snapshot at gate
When a section is locked, the underlying evidence snapshot is preserved. The submission can be reproduced byte-for-byte.
Predicate / equivalence
Side-by-side comparison matrices link to source claims, not screenshots.
Resubmission-ready
Post-clearance changes update the next submission automatically, no rebuilding what didn’t change.
LuminLogic IQ embedded
Draft section summaries with citation, suggest claims aligned to predicate, flag inconsistencies, all logged to the record.
A submission, end to end.
Out-of-the-box for FDA 510(k), EU MDR Annex II/III, MDSAP audit packages, and Health Canada: admin-configurable templates.
Submit to every jurisdiction from one source.
Assemble evidence once. LuminLogic IQ maps it to each framework and tracks readiness per market, no parallel binders.
Submissions lives on the same platform as everything else.
Engineering & DDF
Submissions assemble directly from the DDF, no parallel binder.
Learn moreChange Control
Post-clearance changes flow into the next submission automatically.
Learn moreDocuments
Procedures referenced in submissions stay in sync with the controlled revision.
Learn moreComplaints
Post-market signals feed periodic safety updates and re-submissions.
Learn moreBring the binder into the platform.
See how a 510(k) is prepared from your DDF, with gap analysis and IQ citations baked in.
Using LuminLogic, we were able to streamline our document management and share technical files securely with MethodSense. LuminLogic’s efficient system allowed us to transfer vital information quickly, ensuring our submissions were well-organized and compliant. This software helped us stay on track with the FDA requirements, leading to a faster approval process.
Sven Erdmann
Vice President Technology and Regulatory, Ulrich Medical