AI-Enabled Platform Embeds 25+ Years of Regulatory and Quality Expertise to Accelerate Product Commercialization

RALEIGH, N.C., Sept. 14, 2026 /PRNewswire/ — Today MethodSense® announced the launch of LuminLogic® NextGen, a new AI-enabled quality and regulatory compliance platform that unifies eQMS, regulatory intelligence, submission readiness, and compliance management into a single solution. The platform delivers a fully configured, compliance-ready system in as little as one day rather than months.

At its core is an advanced intelligence layer grounded in 25+ years of MethodSense methodologies and decades of regulatory, quality, and product development expertise across the medical device industry. LuminLogic NextGen automatically adapts to the way each organization works, configuring around each unique business rather than redesigning the business around the platform.

Unlike legacy point solutions, LuminLogic NextGen unifies quality, regulatory, product, clinical, manufacturing, and commercialization into a single connected platform. Teams retain their autonomy while sharing information and workflows through a single source of truth, enabling continuous traceability, real-time visibility, AI-guided automation, and dramatically faster execution. For the first time, global regulatory compliance becomes a business accelerator rather than a cost of doing business.

“We have spent decades solving real-world problems that quietly delay development, submissions, and commercialization,” said Rita King, CEO of MethodSense. “LuminLogic NextGen embeds that expertise into a connected platform, enabling organizations to execute with greater speed, organizational insight, and confidence across the entire product lifecycle.”

Key Capabilities Include:

• Global custom QMS deployed in one day
• Design and deploy validated workflows without developers
• AI-powered gap analysis against ISO standards
• Intelligent analyses, recommendations, and work products generated in minutes
• FDA-compliant real-time collaborative editing
• Continuous traceability across QMSR and EU MDR
• Integrated project management and capacity planning
• Predictive analytics to identify quality and compliance risks

The platform is already helping innovative medical device companies worldwide navigate complex regulatory and quality challenges without slowing development. Longtime MethodSense client OxiWear, developer of an FDA-cleared pioneering ear pulse oximeter, demonstrates the impact of that approach.

“As a startup developing a life-saving wearable, we cannot afford to slow down for compliance or build a large regulatory team,” said Shavini Fernando, Founder and CEO of OxiWear. “LuminLogic gave us a compliant quality system almost immediately, with MethodSense expertise built in. It accelerated product development, unified our team, and gave us confidence through our successful submission and multiple regulatory audits.”

Built from thousands of successful consulting engagements across the medical device industry, LuminLogic® NextGen brings MethodSense expertise directly into the platform, helping organizations move from concept to commercialization faster while maintaining continuous compliance.

About LuminLogic®:
LuminLogic is an AI-enabled eQMS and regulatory compliance platform built by MethodSense for the medical device industry. Powered by LuminLogic IQ, the platform unifies quality, regulatory, product development, and commercialization activities in a single intelligent environment. Learn more at www.luminlogic.com.

About MethodSense®:
MethodSense is a regulatory, quality, product development, and technology consulting company serving the global medical device industry. For over 25 years, it has helped organizations navigate complex quality and regulatory challenges and accelerate the product lifecycle from concept through commercialization. For more information visit www.methodsense.com.

Media Contact:
Mary Elkordy
mary@maryelkordy.com

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SOURCE MethodSense