Quality & Compliance
Bionix products are made under ISO-certified processes and meet FDA requirements, delivering consistent performance you can trust.
Quality & Compliance Resources
ISO Certification
ISO certification means our products are made with consistent quality and strict process controls.
ISO Certification
Quality Policy
Our quality policy reflects a commitment to consistency, safety and performance in every product we deliver.
Quality Policy
FDA Establishment Registration & Device Listing
FDA Establishment Registration & Device Listing show that our facilities and products meet federal requirements for safety and effectiveness.
FDA.gov
