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Access FDA Device Listings, Material Test Reports (MTR), and Declarations of Conformity.
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Deep dive into our ISO 13485 Quality Management System. Grain size control, h7 tolerance, and risk management.
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Interactive tool. Input your product Lot No. to retrieve specific chemical analysis and raw material origin.
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Compliance Change Log
LAST_UPDATED: 2026-01-022025-12-15
MDR Technical File Update (v4.2)
Annex I GSPR checklist updated to reflect latest biocompatibility standards (ISO 10993-1:2018).
Documented
2025-11-20
FDA Device Listing Renewal
Fiscal Year 2026 Establishment Registration fee paid and verified active.
Completed