Innolitics
A full-service software and FDA regulatory partner for medical device companies, specializing in AI-enabled medical device software.
About Innolitics
A full-service software and FDA regulatory partner for medical device companies, specializing in AI-enabled medical device software.
Products
An end-to-end service where Innolitics designs, builds, validates, and helps secure FDA clearance for AI/ML medical software.
A Notion-powered toolkit providing FDA-submission templates and drafting checklists for SaMD and SiMD development.
What customers say
“I learned more from an hour-long Innolitics sales call than an entire paid engagement from other consultants.”
“Co-Founder of Prognosia Breast (acquired by Lunit)”
“VP of Quality and Regulatory Affairs, Buoy Software”
Innolitics’ Enlitic story describes embedded software-development support followed by maintenance, feature development, staff off-boarding assistance, and improvements to regulatory SOPs.
Case studyInnolitics reports reimplementing CorticoMetrics’ AutoRegister prototype, integrating it with MRI and PACS systems, and providing testing and documentation for a planned 510(k). The story establishes submission…
Case studyInnolitics reports building GyriCalc’s C++ algorithm and Django/React application, executing a validation study, and preparing regulatory documentation for NeuroSpectrum Insights. The story reports July 2025 clearance,…
Case study
Security and compliance
As reported by Innolitics. Ask for audit reports before you buy.
- ISO 9001In progress
- IEC 62304Compliant
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