Who We Serve / Medical Devices & MedTech
From FDA navigation to FHIR-native integration.
Digital health regulatory strategy, device-data integration into the clinical workflow, and production governance for device AI.
Entry Doors
Six ways in. One integrated partner.
Regulatory
FDA Digital Health Navigation
SaMD classification, predetermined change control plans, and submission strategy for AI-enabled devices.
Connectivity
FHIR-Native Device Integration
Device data into Epic and MEDITECH workflows: discrete, mapped, and clinically actionable.
Governance
Device AI Monitoring
Post-market performance monitoring, drift detection, and safety scoring through AIGaaS.
Infrastructure
Compliant Cloud
HIPAA- and SOC 2-aligned device-data infrastructure with tested DR.
Build
Product Development
Clinical-grade product engineering from a team that ships its own platforms.
Market
Health-System Access Strategy
Buyer-side insight into how health systems evaluate, procure, and deploy device technology.
Bring medical device data into clinical workflows.
Speak with our MedTech regulatory and interoperability specialists.