How AVIORA devices are built.

Clinical requirements are defined with input from surgeons and procurement teams. Performance specifications are established before any engineering work begins.

Device design follows formal controls aligned to ISO 13485. Design outputs are reviewed and approved before prototyping. Verification confirms outputs meet inputs; validation confirms performance under actual use conditions.

Materials are selected based on biocompatibility, mechanical performance and sterilisation compatibility. All tissue-contact materials are evaluated against ISO 10993 before production use.

Production takes place in controlled environments under documented SOPs. Critical parameters are monitored at defined inspection points. In-process checks are performed and independently verified before each batch proceeds.

Finished devices are validated through IQ, OQ and PQ protocols. Each batch is released against documented acceptance criteria. Risk management files are maintained per ISO 14971.

Devices are packaged in validated sterile barrier systems per ISO 11607. EO sterilisation is performed in validated cycles with biological indicator monitoring to SAL 10⁻⁶.

AVIORA receives devices with full batch documentation — manufacturing records, sterilisation cycle data and certificates of conformity. Lot traceability is maintained from manufacturer to hospital.