Main Purpose
The main purpose of Innolitics is to provide medical device software services, including strategy, development, FDA clearance, and engineering resources for medical device manufacturers.
Key Features
- Strategy: Innolitics offers guidance and strategies for AI/ML and SaMD devices, helping determine the path to market.
- Build and Validate: The company provides turn-key engineering solutions, including software development, AI/ML optimization, cybersecurity, and device verification and validation.
- FDA Clearance: Innolitics assists with 510(k) submission and can draft design documents for FDA clearance in a guaranteed timeframe.
- Expand: The company offers engineering resources for existing medical devices, including web, native, cybersecurity, AI/ML, and interoperability services.
Use Case
- Medical Device Manufacturers: Innolitics works with established device manufacturers looking to break into the SaMD or AI/ML space, enterprises seeking turn-key SaMD solutions, startups needing regulatory documentation help, and clinicians/researchers looking to commercialize their research or ideas.
- Manufacturers in Different Jurisdictions: Innolitics also assists manufacturers already on the market in the E.U., Australia, or other jurisdictions who are looking to submit their devices in the U.S..
