Hospitals don’t want a vendor — they want a partner who arrives with the paperwork already done. Every Bioni install includes a complete compliance pack.
What’s included
IEC 60601-1 declarations of conformity, EMC test reports, ISO 14971 risk-management summary, residual-risk acceptance, TGA conformity-assessment evidence (where applicable), and a full set of test-and-tag certificates for every electrical asset installed.
Audit support
When the hospital is audited — ACHS, internal, or TGA — our compliance team responds to information requests directly. Your biomedical team doesn’t have to chase us for documents.