Quality Statement
Spinecraft’s Quality Policy and Procedures reflect our complete dedication to quality, as well as patient and customer satisfaction. Our comprehensive quality system is designed to achieve high quality standards through strict levels of quality control.
This achievement is indicative of the importance placed on meeting patients’ and customers’ needs and is exemplified by the high quality products being manufactured and offered. Management system is in accordance with 21 CFR Part 820 – Medical Devices, Quality System Regulation and GMP. SpineCraft’s Management System also incorporates the requirements of applicable ISO Standards.
Certificates and Registrations:
§ US FDA Annual Registration of Device Establishment
§ ISO 13485: 2016
This achievement is indicative of the importance placed on meeting patients’ and customers’ needs and is exemplified by the high quality products being manufactured and offered. Management system is in accordance with 21 CFR Part 820 – Medical Devices, Quality System Regulation and GMP. SpineCraft’s Management System also incorporates the requirements of applicable ISO Standards.
Certificates and Registrations:
§ US FDA Annual Registration of Device Establishment
§ ISO 13485: 2016
