Regulatory framework
Bioni operates under the framework of the Australian Therapeutic Goods Administration (TGA) and aligns with internationally recognised standards for medical electrical equipment, quality management, and risk management.
ISO 13485:2016
Medical devices — Quality management systems.
Our quality management system is built around the ISO 13485 framework: design controls, document control, traceability, supplier qualification, CAPA, and post-market surveillance.
IEC 60601-1
Medical electrical equipment — General requirements for basic safety and essential performance.
All Bioni-installed electrical hardware is designed and tested against IEC 60601-1, with specific collateral standards (60601-1-2 EMC, 60601-1-6 usability) applied as relevant.
ISO 14971:2019
Risk management for medical devices.
Every product release includes a documented risk-management file: hazard analysis, risk-control measures, residual-risk evaluation, and post-production information loop.
TGA registration
Australian Register of Therapeutic Goods.
Where applicable, Bioni products are listed on the ARTG. Our regulatory team prepares conformity-assessment evidence and maintains technical files for TGA inspection.
IEC 62304
Medical device software — Software life-cycle processes.
Embedded firmware in Bioni switching hardware is developed under IEC 62304 software life-cycle controls, including SOUP analysis, unit testing, and verification.
Cyber security
TGA medical device cyber security guidance & IEC 81001-5-1.
Our products follow secure-by-design principles: signed firmware, least-privilege networking, vulnerability disclosure, and a documented patching policy. See Product Security for per-product details.
Hospital onboarding
Every Bioni installation includes a compliance pack that contains:
- Test & tag certificates for installed electrical equipment.
- IEC 60601 declarations of conformity.
- Pre-purchase questionnaire (PPQ) responses for hospital biomedical engineering.
- Risk-management summary and residual-risk acceptance.
- Operator manuals and service intervals.
- Cyber-security disclosure pack (network ports, default credentials, patching cadence).
Continuous improvement
Post-market data — field service reports, customer complaints, and adverse-event monitoring — feeds back into our CAPA process. We publish a quality bulletin for hospital biomedical teams whenever a safety-relevant change is rolled out.
Need our compliance documentation?
Hospital biomedical, procurement, or audit teams can request our compliance pack — including ISO 13485 certificate, IEC 60601 test reports, and risk-management summaries — by emailing compliance@bioni.com.au.