Regulatory status and quality assurance
HubX and Health Passport are listed on the Australian Register of Therapeutic Goods. EVEDA is certified to ISO 13485, ISO 27001 and ISO 9001, and takes part in external quality assurance programs. Certificates and the clinical evidence pack are available on request.
Listed on the Australian Register of Therapeutic Goods and with Medsafe New Zealand
HubX and Health Passport are each listed on the ARTG under their device classifications. EVEDA is also listed with Medsafe for the New Zealand market.
EVEDA HubX system
HubX is a portable point-of-care device. It checks 300+ data points across six core health systems in about 15 minutes, from five drops of capillary blood and a urine sample.
EVEDA Health Passport
Health Passport is a personal health record and app. It lets a person see their results and trends over time and share them with their GP.
EVEDA system in New Zealand
The EVEDA system is listed with Medsafe, the New Zealand Medicines and Medical Devices Safety Authority.
Quality control and external quality assurance
EVEDA uses Randox Acusera quality control materials and participates in the Randox International Quality Assessment Scheme (RIQAS) for relevant tests. EVEDA also participates in the RCPA QAP external quality assurance program for relevant testing disciplines, and uses program outcomes as part of its quality assurance processes.
Acusera QC and RIQAS EQA
Acusera quality control materials are used alongside HubX testing. Results for relevant tests are submitted to RIQAS for external quality assessment. RIQAS compares each submitted result with other participating laboratories.
RCPA QAP
EVEDA takes part in the RCPA QAP, the Royal College of Pathologists of Australasia Quality Assurance Programs, for relevant testing disciplines.
The clinical evidence pack covers validation methodology and performance data for qualified clinical and procurement evaluators.
Request the evidence packISO certifications
EVEDA holds ISO 13485, ISO 27001 and ISO 9001 certification.
The international standard for quality management in medical device design, production and servicing.
The international standard for information security management. It sets out how EVEDA protects health data and systems.
The international standard for quality management across the organisation, from design to delivery and support.
Privacy and data security
EVEDA keeps identifiable patient data separate from de-identified population analytics.
Patient control
People control their own record in Health Passport. Data is shared with a healthcare provider only with the person's consent.
Identifiable and de-identified data
Individual care data stays identifiable and access-controlled. DaX works on de-identified, aggregated data.
Privacy law
EVEDA handles personal information in line with the Privacy Act 1988 and the Australian Privacy Principles. See our privacy policy.
Encryption and access
Health data is encrypted in transit and at rest. Access is role-based and logged. EVEDA's information security management is ISO 27001 certified.