EVEDA's diagnostic platform is independently validated, regulatory listed, and certified to international standards. Everything on this page is verifiable, because in healthcare, trust must be earned, not claimed.
EVEDA's hardware and software are separately listed on the ARTG under their respective device classifications, and registered with Medsafe for the New Zealand market.
Portable spot-check analysis system that interconnects with point-of-care equipment, including urine analysis, ECG, blood glucose, ketones, blood pressure, lipid profiles, creatinine, HbA1c, haemoglobin, and spirometry, and coordinates secure distribution of data to a cloud-based architecture for providers, administrators, clinicians, and patients.
Web-accessible mobile platform enabling patients to view and share diagnostic data, preserve health records chronologically, support provider collaboration and patient self-management, integrate wearable device data, and enable video conferencing for telehealth consultations.
The EVEDA diagnostic system is registered with Medsafe, New Zealand's medicines and medical devices safety authority, enabling deployment across both Australia and New Zealand markets under the Trans-Tasman regulatory framework.
EVEDA is actively pursuing regulatory pathways for additional Oceania and international markets. Contact our partnerships team to discuss regulatory status for your region.
EVEDA's point-of-care results are independently validated against internationally recognised reference standards, the same programs used by hospital and commercial pathology laboratories across Australia, New Zealand, and globally.
EVEDA HubX diagnostic accuracy has been independently validated using Randox international quality controls. Randox is one of the world's largest clinical diagnostics companies, manufacturing quality controls and calibrators used by laboratories in over 145 countries.
EVEDA participates in the ongoing Royal College of Pathologists of Australasia Quality Assurance Program, the gold-standard external quality assessment used by virtually every clinical laboratory in Australia and New Zealand.
Detailed validation methodology and performance data are available for qualified clinical and procurement evaluators as part of the EVEDA clinical evidence pack.
Request clinical evidence packEVEDA maintains three ISO certifications covering medical device quality management, information security, and organisational quality, independently audited and maintained.
The international standard for organisations involved in the design, production, and servicing of medical devices. Demonstrates that EVEDA's quality management system meets the regulatory requirements for medical device manufacture.
The international standard for managing information security. Demonstrates that EVEDA has systematic controls protecting patient health data, cloud infrastructure, and organisational information assets against threats.
The foundational international quality management standard. Demonstrates that EVEDA's organisational processes, from design to delivery and support, are structured, documented, and continuously improved.
EVEDA handles sensitive health information under strict governance aligned to Australian privacy legislation, with clear separation between identifiable patient data and de-identified population analytics.
Patients control their own health data through the Health Passport. Data is shared with healthcare providers only with explicit consent. Patients can view, export, and manage their records at any time.
Clinical data used for individual patient care remains identifiable and access-controlled. Population analytics (DaX) operate on de-identified, aggregated data only. Organisations cannot access individual patient records through the analytics platform.
EVEDA's data handling practices are aligned to the Australian Privacy Act 1988 and the Australian Privacy Principles (APPs). For EU/UK individuals, GDPR-equivalent protections apply.
Health data is transmitted and stored using encryption in transit and at rest. Access is role-based and auditable. The cloud architecture is covered under the ISO 27001 certified information security management system.
EVEDA is committed to building a robust evidence base through structured clinical validation, external quality programs, and transparent reporting aligned to recognised standards.
HubX test accuracy is validated using international quality controls (Randox) and benchmarked through external quality assessment (RCPA-QAP). Validation methodology follows principles consistent with the STARD 2015 reporting standard for diagnostic accuracy studies.
EVEDA's approved intended purpose defines the scope of clinical use. HubX is a screening and risk stratification tool. It supports clinical decision-making but does not replace definitive diagnostic procedures where clinically indicated.
Through ongoing participation in the RCPA-QAP program, EVEDA continuously monitors test performance against national laboratory benchmarks. Not just at initial validation, but throughout the operational life of the system.
EVEDA is actively expanding its evidence base through pilot deployments, real-world performance monitoring, and partnerships with clinical and research institutions. Published evidence will be added to this page as it becomes available.