Stop chasing documents. Start running readiness.
Accelerate submissions, strengthen strategy, improve traceability, and maintain continuous readiness across an increasingly complex global regulatory environment u2014 with LuminLogic IQ doing the citation-first gap analysis inside the workflow.
Submission readiness, as a property of the platform.
You don't assemble binders from scratch. Sections pull live from DHF. Gaps surface with citation. Periodic updates are drafted, not invented.
Submission assembly
Sections assemble live from DHF and quality records. Predicate comparison and equivalence matrices link to source claims.
Framework currency
See exactly where every framework, jurisdiction, and product stands u2014 color-coded, drill-down enabled.
Guidance watch
New FDA, EU, and ISO guidance surfaces in your inbox with IQ analyzing which projects it impacts.
Periodic safety updates
PSURs and periodic safety updates assemble from PMS data with one click u2014 IQ drafts narrative for review.
Audit-grade signatures
21 CFR Part 11 signatures bind your medical-affairs concurrence to the exact revision u2014 meaning and intent captured.
LuminLogic IQ embedded
Gap analysis with citation, predicate comparison, claim cross-checking u2014 every IQ touch logged.
A regulatory manager’s week.
A composite week drawn from how LuminLogic customers actually work u2014 surface, assemble, sign, submit.
1 u00b7 Monday u2014 surface
My Office shows framework currency, open submissions, and guidance updates with affected projects called out.
2 u00b7 Mid-week u2014 assemble
Sections assemble from live evidence. IQ flags gaps with citation; you delegate by linking the record gap.
3 u00b7 Review & sign
Medical-affairs and QA concurrence under 21 CFR Part 11. Every signature bound to the exact revision.
4 u00b7 Submit & track
Snapshot at lock. Subsequent submissions update only what's changed u2014 no rebuilding what didn't move.
IQ flagged a software documentation gap against the new FDA guidance before our outside counsel did. We closed it in three days, not three weeks.
David Park
VP Regulatory Affairs, Nyxa Medical
See your submissions assemble themselves. in action.
From MedTech vision to market leadership.
Walk through a real 510(k) u2014 from gap analysis to lock u2014 with one of our regulatory engineers.