Compliance as a competitive advantage.
21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 62304, EU MDR, MDSAP: covered by configurable workflow blueprints, 21 CFR Part 11 signatures, dynamic traceability, and an audit trail any inspector can actually read.
Blueprints you can fork when your interpretation differs.
Compliance, built into the work.
21 CFR 820, 21 CFR Part 11, ISO 13485, EU MDR, MDSAP: mapped to your SOPs and records and kept current, so readiness is a property of the platform, not a project.
Compliance frameworks as blueprints, not bolt-ons.
LuminLogic ships ready for the regulations you operate under, and lets you fork the blueprint when your interpretation differs. No services engagement.
21 CFR Part 11 signatures, native
Author, Review, Approve, Concur: bound cryptographically to the record revision, with meaning and intent captured at signing.
Audit trail by default
Every record interaction, IQ included, is logged, immutable, and exportable in the form auditors actually request.
Validation maintained
Computer system validation under GAMP 5. Each release ships with regression suites and an updated validation summary.
Configurable to your interpretation
Frameworks are blueprints, not constraints. Quality admins tune workflows to your interpretation under 21 CFR Part 11.
Multi-jurisdiction
US, EU, Canada, Brazil, Japan, Australia: one record, jurisdiction-aware reportability and submission tracks.
LuminLogic IQ, citation-first
Every IQ answer cites the underlying clause and the record evidence, never trust without the link to the source.
Compliance shows up across every module.
CAPA
ISO 13485 §8.5.2 + 21 CFR 820.100 baseline, admin-tunable.
Learn moreDocuments
Controlled authoring under 21 CFR Part 11 with retraining on release.
Learn moreChange Control
Impact, approvers, and traceability: all signed under intent.
Learn moreSubmissions
510(k), EU MDR, MDSAP packages from the same evidence base.
Learn moreCoverage you can see at a glance.
LuminLogic tracks your standing against every framework you operate under, clause by clause, and flags gaps before an auditor does.
Walk an auditor through your system live.
See how an inspector-style trace request resolves to evidence in clicks, not weeks.
Working with MethodSense was the best decision we could have made. Their regulatory expertise and understanding of our product helped us navigate a complex situation with the FDA. Their guidance not only ensured compliance but bolstered investor confidence.
Brian Pike
Co-Founder & President, Rhythmedix