Integration into the EHRs your customers run
Software lifecycle evidence
Risk management
Certified cloud for device data
Regulatory, integration, and adoption.
SaMD pathways
510(k), De Novo, and Predetermined Change Control Plan support for software and AI-enabled devices.
Clinician adoption
Device data that lands in Epic and MEDITECH as discrete, mapped, clinically actionable values.
Premarket cybersecurity
Security documentation, SBOM management, and coordinated vulnerability response for fielded devices.
Capabilities.
EHR Integration
Device data into Epic and MEDITECH through documented interfaces clinicians adopt.
Device Cybersecurity
Premarket documentation, SBOM management, and vulnerability response.
AI Governance
Validation evidence for AI-enabled devices under NIST AI RMF.
Regulatory Strategy
Submission planning and evidence assembly for SaMD and digital health.
Device Data Platforms
HITRUST-certified hosting for device telemetry and post-market data.
Provider Deployment Support
Implementation playbooks for the health systems buying your device.
Three ways in.
Submission support
Regulatory strategy and evidence assembly for a specific submission, with the quality artifacts it depends on.
Integration build
Device-to-EHR interfaces and clinical workflow design, delivered with the provider organization in the room.
Sustained operations
Post-market monitoring, security response, and interface support once the device is in the field.
Scoped against your submission timeline.
Thirty minutes with the product and regulatory leads.
Epic, MyChart, Agent Factory, Art, Emmie, and Penny are trademarks of Epic Systems Corporation. MEDITECH and Expanse are trademarks of Medical Information Technology, Inc.