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CompaniesInnolitics

Innolitics

A full-service software and FDA regulatory partner for medical device companies, specializing in AI-enabled medical device software.

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Founded: Not disclosed
Headquarters: Not disclosed
Company size: Not disclosed
Products tracked: 2

Products by Innolitics

2 products

Concept to Cleared DeviceAn end-to-end service where Innolitics designs, builds, validates, and helps secure FDA clearance for AI/ML medical software.0.00 reviewsRegulatory Compliance

Medtech OSA Notion-powered toolkit providing FDA-submission templates and drafting checklists for SaMD and SiMD development.0.00 reviewsRegulatory Compliance

Pricing for Innolitics

Enterprise Custom

This is the broad commercial model reported for Innolitics. Product-level terms are listed below when available.

Concept to Cleared DeviceAn end-to-end service where Innolitics designs, builds, validates, and helps secure FDA clearance for AI/ML medical software.

Pricing model: Enterprise Custom, One Time

Medtech OSA Notion-powered toolkit providing FDA-submission templates and drafting checklists for SaMD and SiMD development.

Pricing model: Enterprise Custom

Trust profile

Security and compliance

ISO 9001

IEC 62304

Product portfolio

Markets

Legal, Risk & Compliance2

Industries served

Healthcare & Life Sciences2 Professional Services2

Company details Public record

Website: innolitics.com
Deployment

Online profiles3

LinkedIn X GitHub