Healthcare Software Development
That Passes Regulatory Scrutiny.
Our founder is CTO of an FDA 510(k)-cleared SaMD. We have navigated the full regulatory process — design controls, risk management, software validation, and pre-submission meetings. We don't just know the standards; we've applied them under FDA review.
What We Build
From FDA-regulated medical devices to clinical workflow digitization — software that meets the highest standards of safety, reliability, and regulatory compliance.
FDA 510(k) Software as a Medical Device (SaMD)
Software that meets FDA SaMD definitions requires a structured development lifecycle, risk management file (ISO 14971), and software documentation package (IEC 62304). We have cleared this process.
- ✓Software Level of Concern determination
- ✓Design controls and traceability matrices
- ✓Risk management documentation (ISO 14971)
- ✓Software validation and V&V testing
HIPAA-Compliant Platforms
Healthcare applications that handle PHI require end-to-end security architecture, access controls, audit trails, and BAA-compliant infrastructure. We design HIPAA compliance in from the start.
- ✓PHI data architecture and encryption
- ✓Role-based access controls and audit logging
- ✓BAA-compliant infrastructure (AWS Healthcare)
- ✓Security risk analysis documentation
Clinical Workflow Digitization
Paper-based or legacy clinical processes converted to modern, integrated digital workflows. Patient intake, scheduling, assessment tools, and reporting — built around clinician workflows, not retrofitted onto generic CRMs.
- ✓Patient intake and digital forms
- ✓Scheduling and appointment management
- ✓Clinical assessment and reporting tools
- ✓EHR/EMR integration
AI in Healthcare
Clinical decision support, automated documentation, patient-facing AI assistants, and diagnostic AI — built with the explainability and audit trail requirements that healthcare regulation demands.
- ✓Explainable AI for clinical contexts
- ✓Clinical documentation automation
- ✓Patient engagement tools
- ✓Model validation and monitoring
Regulatory Expertise — Not Just Awareness
Most software agencies "understand HIPAA" and "have experience with FDA." We have operated under FDA oversight. There is a meaningful difference.
Why This Matters for Your Project
When you hire a generalist software team for a healthcare project, you pay for the learning curve. They discover the regulatory requirements as they build, which means costly architecture changes, documentation retrofits, and delayed submissions. Our team already knows what FDA reviewers look for, what HIPAA auditors flag, and how to structure a software development lifecycle that produces compliant documentation as a natural output — not an afterthought.
Healthcare Work in Practice
Bridges Health
National occupational health provider needed to digitize clinical workflows, patient intake, and scheduling across multiple locations. We delivered a modular platform that streamlined intake and enabled scalable program delivery.
Highmark Interactive Balance Assessment
Stephen Elliot led the development and FDA 510(k) clearance of a balance assessment Software as a Medical Device. This engagement involved full IEC 62304 compliance, ISO 14971 risk management, and FDA pre-submission strategy.
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