MethodSense has 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 one solution.
At its core, is an advanced intelligence layer trained on 25+ years of MethodSense methodologies and decades of regulatory, quality, and product development expertise across the medical device industry. The company says LuminLogic NextGen automatically adapts to the way each organisation works, configuring around each unique business rather than redesigning the business around the platform.
MethodSense says that LuminLogic NextGen unifies quality, regulatory, product, clinical, manufacturing, and commercialisation 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 commercialisation,” said Rita King, CEO of MethodSense. “LuminLogic NextGen embeds that expertise into a connected platform, enabling organisations to execute with greater speed, organisational insight, and confidence across the entire product lifecycle.”
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 wearable 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.”
