Built for the way MedTech teams actually work.
A connected platform that brings quality, regulatory, engineering, governance, and business operations together, so MedTech organizations can move faster, with confidence. Built by the regulatory team behind MethodSense, with 25+ years guiding products to market.
Modern MedTech deserves a modern operating platform.
For years, MedTech organizations have relied on a patchwork of applications, spreadsheets, emails, and manual processes to manage complex product development and compliance activities.
While each tool may address a specific need, the result is often duplicate effort, delayed decisions, inconsistent data, and limited visibility. Disconnected tools create disconnected teams, fragmented information, and unnecessary risk.
LuminLogic was created to bring these critical functions together within a single connected environment that supports collaboration, compliance, and execution.
The old way
A patchwork of point tools
- Spreadsheets & email threads
- Legacy, siloed eQMS modules
- Document repositories no one trusts
- Disconnected project & engineering tools
- Fragmented data, no traceability
With LuminLogic
One unified platform
- Quality, regulatory & engineering in one environment
- Shared infrastructure & real-time visibility
- Dynamic traceability built into the process
- Guided workflows that drive execution
- LuminLogic IQ embedded where work happens
LuminLogic emerged from years of helping MedTech organizations navigate product development, quality systems, regulatory submissions, commercialization, and operational growth.
Across hundreds of client engagements, the MethodSense team repeatedly encountered the same challenge: organizations were forced to adapt their processes to software that was never designed for the realities of MedTech innovation.
LuminLogic was built to solve that problem, from real-world MedTech experience, not software assumptions.
Created by the team behind MethodSense.
From systems of record to systems of execution.
Most enterprise software manages information. LuminLogic is designed to manage work, transforming how MedTech organizations execute critical business processes through guided workflows, intelligent automation, embedded expertise, and real-time visibility.
System of record
Stores information
- Holds documents and records
- Waits for people to act
- Reporting after the fact
- Administration-heavy
System of execution
Manages the work
- Guides workflows step by step
- Automates routine tasks
- Real-time visibility into progress & risk
- Less admin, more innovation
Purpose-built for MedTech innovation.
Connected by design
Quality, regulatory, engineering, governance, and business processes operate within a single unified environment.
Guided by expertise
Industry best practices are embedded directly into workflows and user experiences, not left to chance.
Ready to scale
Supports organizations from early-stage innovators through commercial growth, without re-platforming.
Built for visibility
Gives leadership real-time insight into progress, risk, compliance, and execution across the company.
Meet the experts behind LuminLogic.
LuminLogic was not created by a software company searching for a market. It was built by professionals who have spent their careers helping MedTech organizations navigate regulatory complexity, establish quality systems, accelerate commercialization, and bring life-changing technologies to market.
Rita King, MBA
Chief Executive Officer
A regulatory strategist, technologist, and professional auditor who has spent decades helping medical device innovators navigate FDA, EU MDR, and global requirements. As founder and CEO of MethodSense, Rita’s vision for LuminLogic is rooted in the belief that compliance and operational excellence should be competitive advantages, not administrative burdens.
Russ King, MA
President
A long-time life sciences executive with more than 30 years of industry experience. Russ’s leadership helps ensure LuminLogic aligns technology, business processes, and organizational execution to support sustainable growth and operational excellence.
Richard Holcomb
Chief Growth Officer
A serial entrepreneur, investor, software executive, and M&A advisor with more than 40 years of experience building and scaling technology companies. His expertise in software innovation and commercialization helps shape LuminLogic’s direction as a next-generation platform for MedTech execution and compliance.
Evangelia Evdaimon
Vice President of Quality
A professional auditor with more than 20 years of experience in quality systems, compliance management, and operational excellence. Her expertise ensures LuminLogic workflows, templates, and dashboards align with industry standards while supporting audit readiness, traceability, and continuous compliance across the product lifecycle.
Experience embedded into every workflow.
Unlike generic enterprise software, LuminLogic is informed by practical experience gained through regulatory submissions, quality initiatives, audits, remediation projects, and operational transformation: encoded into guided workflows, automation, and best-practice templates.
A quarter-century of MedTech regulatory work.
- 2001
MethodSense founded
Started as a regulatory consultancy guiding MedTech companies through FDA 510(k) submissions and ISO 13485 audits.
- 2010
First LuminLogic platform release
Encoded MethodSense consulting templates into a working eQMS, documents, CAPAs, signatures, and audit trail on one framework.
- 2016
EU MDR coverage launched
Native technical-documentation, PMS, and clinical-evaluation workflows. Customers shipped their first CE Marks on the platform.
- 2022
100th customer milestone
From AI/ML startups to combination-product enterprises, 100 MedTech teams running on LuminLogic across 22 countries.
- 2025
LuminLogic IQ in beta
First context-aware AI capability shipped, root-cause analysis inside CAPA editors, grounded in real MethodSense investigations.
- 2026
LuminLogic NextGen launches
Full platform rebuild, unified content framework, IQ across every workflow, validated QMS out-of-the-box, white-glove onboarding.
Helping innovators bring life-changing technologies to market.
Connecting people, processes, data, and decisions within a single platform designed for MedTech.