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Medical Device Software
FDA-compliant software for devices and diagnostics. We understand the regulatory path.
HIPAA Isn't Optional. Neither Is Quality.
We've been burned-agency recovery for healthcare orgs who hired teams that didn't understand the space. HIPAA compliance isn't a checkbox—it affects architecture, hosting, logging, everything. We get that. We've shipped software that handles millions of patient interactions without a single compliance issue.

Solutions
We start with the operating constraints and build toward the systems, automations, integrations, and product surfaces that matter most.
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FDA-compliant software for devices and diagnostics. We understand the regulatory path.
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Video consultations, scheduling, prescriptions, payments. Built for clinical workflows, not just tech demos.
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Electronic health records with real interoperability. HL7 FHIR, integrations that work.
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Population health, clinical decision support, outcome tracking. Data that improves care.
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ML for medical imaging, symptom analysis, triage. Assistive AI that helps clinicians, not replaces them.
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Claims processing, eligibility verification, billing. Get paid faster, with fewer denials.
Challenges
HIPAA compliance that actually holds up to audit
Data that flows between systems instead of sitting in silos
Patient privacy without compromising care
Integrating with legacy hospital systems
FDA and other regulatory requirements
Compliance and security
HIPAA
Designed for auditability
GDPR
Designed for auditability
SOC 2 Type II
Designed for auditability
FDA 21 CFR Part 11
Designed for auditability
Why Lumon
Not 'we read the requirements.' We've been audited. We've passed. Multiple times.
HL7 FHIR, proper integrations. Your data flows where it needs to go.
Interfaces that patients can actually use. Accessibility built in.
Encryption, access controls, audit logs. The full stack, done right.