Regulated by design
Security, privacy, quality management and regulatory evidence aren't features — they surround the entire NerveDX lifecycle as core product commitments.
GDPR-Oriented
Data protection by design and default for sensitive, identifiable clinical EEG. Transparent handling, minimised exposure and responsible processing.
ISO 13485 Aligned
Quality management thinking applied to software development and the product lifecycle, aligned with ISO 13485 expectations for medical device software.
Tenant Isolation
Multi-tenant architecture designed so institutional data stays separated and protected — a first-class infrastructure requirement, not an add-on.
Audit Trail
Persistent, tamper-evident records across review, annotations, model outputs and clinical sign-off for full traceability.
FDA-Aligned
Development strategy aligned with FDA expectations for clinical software, from design controls through to validation and intended use.
EMR-Ready
Integration architecture built to hand off results into hospital systems without weakening security or auditability.
What we build into every release
| Commitment | Status context |
|---|---|
| Quality management system backdrop | Product and process development aligned with ISO 13485 principles for medical device software. |
| Privacy by design | GDPR-aligned data protection, minimisation and controlled access across the platform. |
| AI governance | Model provenance, validation and documentation meet the expectations of emerging AI regulatory frameworks. |
| Auditability | Every step — from import through sign-off — leaves a documented, reviewable record. |
| Operational analytics | Service-level visibility into workflow, turnaround and reviewer workload to drive ROI measurement. |
Designed for the questions hospitals ask
Security and compliance work is framed so clinical, IT, procurement and commercial diligence can inspect the same operating evidence.
Data boundaries
Institutional separation, access controls and deployment choices are treated as core architecture decisions.
Clinical accountability
AI supports triage; clinicians confirm, correct and sign off with an auditable record of the decision path.
Scale evidence
Operational analytics support service-level ROI measurement while preserving privacy and auditability.
“Regulatory and QMS thinking is embedded in the NerveDX architecture, so commercialisation doesn't force a redesign — it's a continuation of how the product is already built.”NerveDX — Product Architecture
Have compliance or security questions?
Our team can share detailed architecture and governance information under NDA.