ISO 13485: 2016SpineCraft's comprehensive Quality System is designed to achieve high quality standards through strict levels of quality control. SpineCraft's achievement of quality is indicative of the importance placed on meeting patients' and customers' needs and is exemplified by the high quality products being offered.
The SpineCraft Quality Policy reflects our Company's dedication to Quality. In order to ensure the Achievement of Excellence through a comprehensive and effective Quality System, we are engaged in an ongoing focus and commitment to the following objectives:
§ Improving human welfare through enhanced quality of life and restored health,
§ Achieving high quality standards through compliance with requirements and maintenance of the effectiveness of the
Quality Management System, and
§ Providing total customer satisfaction, both by medical providers and patients, from design to end use.SpineCraft's Quality
Management System is in-accordance with 21 CFR Part 820 - Medical Devices, Quality System Regulation - and GMP. SpineCraft's Quality Management System also incorporates the requirements of applicable ISO Standards, as well as European Medical Device Directives. SpineCraft emphasizes a total quality assurance approach to all aspects of business.
Awareness of Quality Systems and procedures is maintained through employee training and is practiced company-wide. The SpineCraft Quality Management System provides the organizational structure to ensure that products are processed, manufactured, controlled, and distributed according to the appropriate regulatory requirements and corporate policies/procedures.
Continuous quality improvement is the basis for the Quality Management System. The periodic reviews of the system identify the strategic plans required to develop, implement, and modify the Quality Management System and identify the processes, controls, equipment, fixtures, resources, and skills necessary to meet ongoing quality requirements.
SpineCraft is a U.S. FDA-registered medical device establishment and is certified to the international quality standards (ISO 13485:2003) for the design, manufacture, and distribution of Spine Implants and Instruments as well as Orthobiologics.
Certificates and Licenses:
§ US FDA Annual Registration of Device Establishment
§ ISO 13485: 2016