Global Quality Certificates.
Download authentic, audit-ready certification data for ValidTi's manufacturing infrastructure. These documents verify our commitment to ISO 13485 standards and medical-grade titanium protocols.
01 Primary Certification Directory
ISO 13485:2016
Medical Devices — Quality Management Systems. Comprehensive certification covering the design, development, and manufacturing of medical-grade titanium alloys.
FDA Establishment
Official US FDA Registration for SinoTitanium Metals (Xi'an) Co., Ltd. Includes current Device Listing for titanium discs and rods used in implantable prosthesis.
CE MDR Compliance
Declaration of Conformity according to EU MDR 2017/745. Technical Files verified for Annex I General Safety and Performance Requirements.
02 Material Safety & Biocompatibility Vault
Beyond QMS certifications, ValidTi maintains a rigorous secondary documentation protocol to ensure every batch meets biocompatibility and environmental standards.
Forensic Authentication Protocol
Every ValidTi certificate is protected by a digital watermark and forensic QR code. If you are an auditor and suspect a forged document, please use our verification terminal for real-time mill authentication.
Preparing for a Notified Body Audit?
Authorized distributors and OEM partners gain access to our full "Technical File Support" package, including internal audit reports and raw material traceability logs.
Forensic Support Tier // 24H Response Protocol
Quality & Regulatory Resources
FDA MTR Database
Direct access to mill test reports and FDA establishment data.
Forensic MTR Audit SOP
Learn how to cross-reference these certificates with physical material markings.
2025 Regulatory Forecast
How upcoming EU MDR changes affect material certification requirements.