Inveris Digital
IRIS provides AI-driven institutional intelligence for regulated MedTech and life-science organizations, capturing undocumented knowledge from code and engineers to make it defensible for compliance and migration projects. The platform runs in the customer's own cloud, with a proof-of-concept at near-zero cost and production deployment under $100K fixed fee, with IP assigned directly to the client.
- Regulatory & Compliance Technology
- Artificial Intelligence
- Software Only
Funding
Founders
Founder details are not available yet.
Product
Problem
Regulated MedTech and life-science organizations face significant risk when the engineers who understand legacy systems retire, leaving undocumented design rationale and business rules that are impossible to reconstruct. Investigators, regulators, and migration programs require auditable explanations of systems that nobody left can explain, creating board-level risk and multi-year program delays.
Solution
IRIS captures undocumented knowledge from both code and the engineers who wrote it, making it defensible enough to sign and put to work. The platform integrates with existing data warehouses, lakes, and pipelines, then goes beyond recorded documentation to extract the reasoning that decides edge cases from the people who still hold it. IRIS produces auditable specifications, FDA-ready documentation, and verified processing rules that can be automated and defended when questioned. The platform runs in the customer's own cloud, with a named engineer signing off on deliverables and IP assigned to the client outright.
Target Audience
Primary customers are regulated MedTech and life-science organizations facing compliance audits, regulatory submissions, or legacy system migration projects where institutional knowledge is concentrated in a few individuals.
Features
- Captures tacit knowledge from engineers through structured interviews in their own language, combined with source code analysis
- Generates auditable specifications of how business rules actually resolve, verified by the people who built them
- Produces FDA-ready design rationale documentation from device firmware and existing design files
- Runs entirely in the customer's own cloud environment with no external data exposure
- Available on AWS Marketplace for streamlined procurement without a new vendor cycle
- Fixed-fee production deployment under $100K with a near-zero-cost proof-of-concept underwritten by IRIS