IVD Regulatory Pathway
Established Pathway for IVDR, & FDA Approval.
Axxin's experienced team has detailed expertise in product design, development, and manufacturing in advanced technology products for worldwide markets with infrastructure to assist in obtaining regulatory approvals.
Supporting IVD, Point of Care,
Medical Device Regulatory Compliance Projects
Axxin instruments are designed and manufactured under ISO 13485 and 21 CFR part 820 compliant QMS controls, and are manufactured within validated facilities certified for production of regulated medical devices.
Axxin instruments have demonstrated compliance and regulatory submissions for FDA, IVDR and TGA and others. DHF compliance incorporates, IEC 61010 safety, IEC 60601 EMC FDA requirements, IEC 62304 Software lifecycle. Cyber Security and Encryption, Patient data security, REACH, RoHS, WEEE, and European and US transport packaging requirements and ISO 14971 Risk management. These support services may be of assistance as your application moves towards an IVD regulatory submission including FDA, CLIA waived, IVDR and TGA submissions.
IVD Platforms
Under a Project, Supply and Quality agreement Axxin can provide IVD instrument data pack, integrated project DHF and customised functions for cartridge and instrument as part of a project for IVD diagnostics or advance applications. This can include customised workflow elements, instrument features, cartridge volumes and algorithm and software functions.
