About Innolitics
Innolitics is a software and regulatory consulting firm that helps medical device companies commercialize and FDA-clear software and AI/ML-driven devices. We combine medical device software engineering, AI/ML, cybersecurity, and FDA regulatory expertise on a single team to design, build, and document SaMD and related systems. With experience across 70+ medical device projects since 2012, we focus on fast, high quality 510(k) submissions and compliant software that brings clinical innovations to market.
Product Categories
AI / ML / LLM TechnologiesAdvanced Visualization / Processing / AnalysisCDS (Clinical Decision Support)Consulting & ContractingDigital Pathology
