Compliance & Regulatory Documentation
Access our medical certifications, FDA clearances, and safety data sheets to ensure total transparency and quality assurance in every piece.
ISO 9001:2015
Oct 2023Medical devices — Quality management systems — Requirements for regulatory purposes.
Grade 23 Titanium
Jan 2024Material Safety Data Sheet for medical-grade Ti-6Al-4V ELI titanium alloys.
EO Sterilization
WeeklyBatch verification for Ethylene Oxide sterilization cycles ensuring 10^-6 sterility level.
CE Certification
Valid 2026European Union compliance documentation for Class IIa medical-grade piercing supplies.
Biocompatibility
Nov 2023Comprehensive lab results confirming cytotoxicity, sensitization, and irritation testing.
316LVM Surgical Steel
Dec 2023Mill certificates for implant grade surgical steel (ASTM F138 compliant) for purity.
Traceability Log
Real-timeComplete history of component sourcing and production environmental controls.
Clinical Data
Updated 2024Peer-reviewed studies on long-term safety of implant materials in body jewelry.
Need a specific technical document?
Our regulatory affairs team can provide custom reports, batch-specific mill certificates, and specialized biocompatibility audits for high-volume enterprise and medical partners.