FDA COMPLIANT
QualityAssurance
Every surgical guide undergoes rigorous quality control following FDA 21 CFR Part 820 and ISO 13485:2016 standards. Full traceability from design to delivery.
FDA 21 CFR Part 820
Quality System Regulation compliance for medical device manufacturing. Documented procedures for design controls, production, and corrective actions.
ISO 13485:2016
International quality management system standard for medical devices. Risk management integration per ISO 14971. Full audit trail and CAPA processes.
Three-Tier QC Inspection
Design validation before production. In-process dimensional checks during milling and printing. Final inspection for fit, accuracy, and surface finish.
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