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LuminLogic® NextGen is here.
The AI-enabled eQMS & regulatory compliance platform.
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Platform
Platform
Platform overview
One company. One system.
My Office
Operational command center
QMS in a Day
Compliant QMS, ready to move
Live Collaboration
Real-time, version-safe editing
Workflow Automation
Routing, approvals, signatures
Regulatory Intelligence
25+ years, in workflows
Connected Ecosystem
ERP, CRM, engineering, quality
Quality modules
CAPA
Investigations & effectiveness
Documents & Procedures
Author, review, control SOPs
Change Control
CRs, impact, approvals
Complaints
Intake, triage, MDR / vigilance
Training & Competency
Role-based, auto-retrain on release
Product & regulatory
Engineering & DHF
Design & Development, risk, V&V
Submissions
510(k), EU MDR, Tech Files
Supplier Quality
AVL, audits, SCARs
Project Management & Blueprints
Project Management connected to regulated execution
LuminLogic IQ
AI operational intelligence, embedded where regulated work happens.
Explore LuminLogic IQ
Workflows
Plan & build
Build Your Quality System
Proven QMS foundation, ready faster
Manage Design & Development
Requirements to commercialization
Launch & change
Drive Regulatory Submissions
Continuous submission readiness
Manage Document Changes
Collaborate, review, publish
Manage Change Control
Evaluate, approve, verify
Sustain & lead
Coordinate CAPA & Investigations
Root cause to verified resolution
Coordinate Training
Competency & workforce readiness
Prepare for Audits
Continuous, evidence-ready
Lead with Confidence
Operational visibility for leaders
Workflows overview
How regulated work gets done. Connected workflows across the lifecycle.
Explore all workflows
Who Benefits
By team
Quality Teams
Continuous readiness, less admin
Regulatory Teams
Submission readiness, every day
Engineering Teams
End-to-end traceability by design
Leadership Teams
Operational visibility for leaders
By organization
Startups & Emerging MedTech
Preserve runway, reach milestones
Enterprise Organizations
Scale without sacrificing control
Who Benefits overview
Built for every stage of growth, from startup to global enterprise.
Explore all audiences
Why LuminLogic
Intelligence & expertise
Regulatory Intelligence
25+ years, operationalized in workflows
LuminLogic IQ
AI that understands regulated work
Connected by design
Connected Execution
Everything works together
Traceability by Design
Evidence built into the process
Built to last
Built for How You Work
Adapts to your organization
Future-Ready Architecture
Built for what’s next
Competitive Leadership
See how LuminLogic measures up against legacy eQMS platforms.
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Company
About LuminLogic
25+ years of MedTech regulatory expertise
News center
Press releases & announcements
Blog
Regulatory insights and product updates
Why MethodSense
The team and story behind LuminLogic
Partners & Ecosystem
A connected MedTech ecosystem
Contact
Talk to sales, support, or partnerships
Pricing
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