Healthcare QA is a compliance discipline
When a bug in a general SaaS app costs a bad review, a bug in a healthcare app can cost a patient. Regulators (FDA, HIPAA, HITRUST, IEC 62304) treat QA artifacts as first-class evidence — and reviewers know what real evidence looks like.
Bytenexa builds test suites and documentation with audit-readiness baked in from day one: traceability matrices, signed test-execution records, protected PHI handling, and reproducible builds.
What we test
EHR / EMR Platforms
Epic, Cerner, Athena integrations, custom EHR builds. Charting, orders, results, medication reconciliation.
HL7 / FHIR Integrations
Message conformance, ADT / ORM / ORU workflows, FHIR R4 resource validation.
Telehealth Applications
Video quality, session integrity, cross-device continuity, waiting-room flows.
Patient-Facing Portals
Accessibility (WCAG 2.2 AA), multi-language, secure messaging, appointment booking.
Medical Device Software
IEC 62304-aligned test protocols, risk-based test design, verification-and-validation packages.
Claims & Billing
837/835 X12 EDI flows, denial handling, prior-authorization workflows.
Compliance we design around
- HIPAA — PHI-safe test data, synthetic data generation, secure test environments
- HITRUST CSF — control-mapped test evidence
- FDA 21 CFR Part 11 — electronic records, audit trails, e-signatures
- IEC 62304 — medical-device software lifecycle
- GDPR + state privacy laws for patient data
How we work with health-tech teams
Typical engagement: a QA automation program on the platform layer, backed by manual exploratory testing on clinical workflows, and API testing across HL7/FHIR interfaces. Everything documented for your compliance file.