Healthcare software, built to the bar the regulator expects.
Patient apps, clinician portals, EMR integrations and device data platforms — engineered with HIPAA, DPDP and IEC 62304 in mind from the first sprint, by a team that has shipped in regulated environments.
- HIPAA & DPDP aware
- IEC 62304 & SaMD experience
- Full audit trails by design
- ISO 14971 risk-aware engineering
Concrete outcomes, not buzzwords
Patient apps & clinician portals
Multi-tenant web and mobile apps with role-based access and HIPAA-aware patterns.
Device data & remote monitoring
Ingestion pipelines for medical-device telemetry, with triage dashboards for clinicians.
EMR / EHR integration
HL7 v2 and FHIR integrations, document exchange and clinical context bridging.
Compliance reporting
Auditable adherence, outcomes and insurance-ready reporting — one click, fully traceable.
Telemedicine & care workflows
Scheduled visits, secure messaging, e-prescriptions and care-plan tooling.
Multi-tenant clinic / DME systems
Organization, location and clinician hierarchies with isolation and full audit trails.
What we work with
Engineering
Health interoperability
Regulatory experience
A deliberate sequence
Discovery & risk framing
Clinical workflows, data flows and a first-pass risk file — the boundary we'll engineer to.
Architecture
Tenant isolation, audit-trail-by-default and a controlled interface to any cleared device.
Build
Two-week sprints with traceable requirements and design history — V&V-friendly by construction.
Launch & operate
Monitoring, incident response and continued evolution within your quality system.
Honest about cost and scope
Healthcare engagements vary widely with regulatory scope. We start with a short, fixed-scope discovery to produce a costed plan you can take to your QMS / regulatory lead before committing to a build.
A taste of what this looks like in production
Clinician Oversight Platform for an FDA-cleared CPAP Product
Reduced clinician review time by 60% across 5,000+ patients.
Read case studyQuestions buyers usually ask us
Will you sign a Business Associate Agreement (BAA) under HIPAA?
Yes, where applicable. We routinely work under BAAs and within your existing privacy and security policies.
Have you worked on Software as a Medical Device (SaMD)?
Yes. We've engineered SaMD-adjacent systems under IEC 62304 and ISO 14971 risk management, and supported FDA 510(k) documentation. Final clearance rests with your QMS and regulatory team; we engineer to that bar.
How do you handle PHI / patient data?
Least-privilege access, encryption in transit and at rest, region-pinned storage, full audit logs of reads and writes, and clear data-flow documentation so your privacy officer sees exactly what happens where.
Can you extend a system that already has FDA clearance?
Often the cleanest pattern is a separate, read-derived application that doesn't expand the cleared device's boundary. We've done this and will design with your regulatory lead before writing code.
Do you handle FHIR / HL7 integrations?
Yes. FHIR R4 is our default for new work; we also integrate with HL7 v2 estates and basic DICOM workflows when needed.
What does an engagement look like?
A short discovery to align on clinical workflow, risk and architecture, then two-week sprints with working software. We integrate with your QMS rather than working around it.
Ready to start?
Tell us about your project. We respond within one business day.