The AI-enabled eQMS & Regulatory Compliance Platform.
From MedTech Idea to Market Leader. Faster.
Built by MethodSense and grounded in 25+ years of regulatory and quality expertise, LuminLogic® NextGen connects Quality, Regulatory, Engineering, Leadership, and project execution in one validated environment. Intelligent guidance, integrated workflows, project management, and end-to-end traceability reduce complexity, accelerate execution, and maintain continuous readiness.
Compliance shouldn't slow innovation.
When quality and regulatory teams work with connected evidence, adaptable workflows, and shared visibility, compliance becomes a foundation for faster development, confident decisions, and successful commercialization, friction instead of momentum.
That just cut days off our next audit prep.
More than a system of records.
Traditional eQMS platforms store records. LuminLogic NextGen drives operations. Powered by LuminLogic IQ, AI-assisted workflows, embedded regulatory expertise, and connected operational systems orchestrate quality, regulatory, training, engineering, and submission activities across the product lifecycle.
AI inside the workflow, not bolted on.
LuminLogic IQ embeds AI directly inside the workflows your teams already run. CAPAs, complaints, change requests, submissions, and investigations all get context-aware assistance, not a separate chatbot window.
IQ reads the record, understands the regulatory context, and surfaces the next action with citations to source records and clauses.
- Embedded in CAPAs, complaints, change requests, submissions, investigations
- Context-aware on device class, regulatory pathway, and product type
- Always traceable to source records, not invented content
From records to recommendations.
Context-aware recommendations surface the next required action, the right owner, and the right reviewer. Regulated work moves forward instead of waiting in queues or buried inboxes.
Priorities adapt as records change, so teams always know what to do next, who owns it, and when it’s due.
- Next-action recommendations with owner, reviewer, and due date
- Risk-aware routing across departments and approval chains
- Surfaced where work happens. My Office, the record, and on mobile
Expertise encoded into the platform.
Grounded in 25+ years of MethodSense experience across QMSR, ISO 13485, EU MDR, MDSAP, IEC 62304, ISO 14971, and 21 CFR Part 11. The platform reflects how regulated work is actually done, not a generic vendor playbook.
Frameworks, blueprints, and reference content are maintained by MethodSense as regulations evolve, so your operations stay aligned.
- QMSR, ISO 13485, ISO 14971, IEC 62304, EU MDR, MDSAP, 21 CFR Part 11
- Class II and III, SaMD, AI/ML, diagnostics, combination products, hardware
- Functional area and project blueprints maintained by MethodSense
Operate like one company.
Quality, Regulatory, Engineering, and leadership coordinate inside one connected system. Shared infrastructure, real-time visibility, dynamic traceability, and active task routing across departments and sites.
Records, training, change requests, and approvals all stay in sync, so no team is operating from a stale copy or a parallel spreadsheet.
- Unified Quality, Regulatory, Engineering, Training, Submissions
- Dynamic traceability across documents, CAPAs, training, and supplier records
- Enterprise project and task management spanning the entire company
Audit readiness as a daily habit.
Dynamic traceability and evidence packages assemble themselves from live operational data. Audit prep becomes a daily habit, not a fire drill.
Coverage by clause, by framework, and by jurisdiction is maintained continuously, so teams walk in ready instead of scrambling.
- Evidence packages assembled from live data, one-click export
- Clause-by-clause coverage status maintained continuously
- 21 CFR Part 11 signatures and audit trails attached automatically
Built for the way regulated teams actually work.
LuminLogic NextGen organizes quality and regulatory operations around real-world workflows instead of siloed modules, from building your quality system to preparing for audits and coordinating submissions.
Build your QMS in weeks, not quarters.
Deploy a personalized, audit-ready quality system. NextGen ships a MethodSense-authored framework that LuminLogic IQ tailors to your device class, regulatory pathway, and operating model.
- Quality Manual, SOPs, templates, and forms: personalized for your product
- QMS in a Day available for rapid bootstrapping
- Backed by 25+ years of MethodSense audit experience
Keep every project connected to execution.
Coordinate teams, milestones, dependencies, approvals, and readiness while keeping project plans connected to the regulated work required for successful execution.
- Align cross-functional teams around shared milestones, responsibilities, and deliverables
- Identify project risks, dependencies, and readiness gaps before they affect critical timelines
- Connect project plans directly to workflows, approvals, evidence, and regulated deliverables
Make audit prep a daily habit, not a fire drill.
Assemble audit evidence packages from live data, with continuous traceability and 21 CFR Part 11 signatures already attached. Continuous inspection readiness, no last-minute scrambling.
- Structured by clause, maps directly to auditor findings
- Live coverage status for QMSR, ISO 13485, MDSAP, EU MDR
- Evidence packs exported with one click, fully traceable
Training that follows the document, automatically.
When an SOP changes, training assignments, quizzes, and effectiveness checks update with it. No spreadsheet, no Slack DMs, just a connected workflow.
- Courses, quizzes, and effectiveness validation in one place
- Auto-assignment from document revisions and role changes
- On-time / due-soon / overdue tracking surfaced in My Office
Change control with every downstream impact attached.
NextGen routes change requests through the right approvals and surfaces every record, training assignment, and SOP that needs to move with the change.
- Triggered actions assembled automatically from linked records
- Approval routing aware of risk, department, and 21 CFR Part 11 signatures
- Dynamic traceability across documents, CAPAs, training, and supplier records
Drive submissions from the same records the team works in.
Align quality, engineering, and regulatory documentation through connected submission workflows. LuminLogic IQ helps draft and structure submission content directly from your design or technical documentation.
- 510(k), EU MDR, MDSAP-aligned templates and structures
- Incomplete sections are marked with TBD indicators to preserve accuracy
- Every paragraph linked to its source record for review
Your operational command center.
My Office delivers a personalized operational workspace that surfaces action items, approvals, training requirements, signatures, notifications, and workflow priorities in one intelligent environment. The dashboard reduces administrative overhead while improving operational visibility across quality, regulatory, and organizational workflows.
Real-time collaboration for regulated teams.
Collaborate on controlled documents directly within the platform using live editing, workflow-aware version control, and audit-safe publishing.
Multiple users can work simultaneously while maintaining complete traceability, approval integrity, and operational continuity.
Regulatory intelligence embedded into operations.
Operational workflows carry embedded regulatory expertise, grounded in 25+ years of MethodSense experience. Audit readiness becomes a daily habit, not a fire drill.
- 21 CFR Part 820
- 21 CFR Part 11
- ISO 13485
- ISO 14971
- IEC 62304
- EU MDR
- MDSAP
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01 Embedded expertise
Operational workflows informed by 25+ years of MethodSense regulatory and quality experience across MedTech submissions, audits, and quality systems.
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02 Evolving regulations
Maintain alignment with changing global compliance expectations across QMSR, ISO 13485, ISO 14971, IEC 62304, EU MDR, and MDSAP, across product types and markets.
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03 Audit readiness
Preserve traceability, approvals, and operational accountability continuously, so evidence packages assemble from live data, not last-minute scrambles.
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04 Operational guidance
Surface workflow priorities and next operational actions automatically, so teams know what to do next, who owns it, and when it's due.
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05 AI-informed workflows
LuminLogic IQ accelerates reviews, coordination, and operational execution with context-aware AI embedded directly in regulated workflows.
One company. One system. Connected.
LuminLogic NextGen integrates directly into the operational ecosystem of modern MedTech organizations.
Using APIs and connected workflows, the platform coordinates ERP, CRM, engineering, training, quality, and regulatory systems to reduce silos and improve operational continuity across the organization.
Built for operational confidence.
Compliance as a competitive advantage. NextGen reduces operational friction, accelerates regulated workflows, improves audit readiness, and delivers visibility across the product lifecycle.
Confidence
Continuous audit readiness and operational accountability.
Speed
Accelerate quality and regulatory execution.
Visibility
Operational awareness across teams and workflows.
Reduced burden
Eliminate disconnected admin processes.
Readiness
Move products toward commercialization faster.
Better project execution
Keep teams, milestones, dependencies, approvals, and readiness activities aligned through connected workflows.
“LuminLogic has been instrumental in our regulatory success. We’re now selling in 38 countries, have our CE Mark, and passed multiple audits, including ISO 13485 certification. Reviewers have remarked that our quality system is stronger than most startups they’ve seen, and I credit LuminLogic for much of that. The system ensures that we meet both US and international standards with the least possible effort, helping us grow without unnecessary regulatory hurdles.”
Peter Galen
Co-Founder, Chief Innovation Officer, Hemex Health
See LuminLogic in action.
From MedTech vision to market leadership.
LuminLogic NextGen combines AI-enabled quality and regulatory operations, intelligent workflows, connected systems, and operational visibility to accelerate commercialization, strengthen compliance, and move MedTech companies forward with confidence.