Abstract
The development of spinal products must obey strict quality assurance guidelines. The uniqueness of orthopedic R&D is reflected in the requirements of the main steps: product design, strength analysis and structural optimization, functional analysis and evaluation, and surgical evaluation. Design process of the Integrated Screw-Hook System by Sanyou Medical includes design evaluation and validation, cadaver surgery, FEM simulations, biomechanical experiments, mechanical experiments on the implants, biocompatibility test of materials, and risk assessment evaluation of design. Industrial production process and product quality control are also discussed.
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Liu, M.M. (2018). Integrated Screw-Hook Development. In: Ni, B., Guo, X., Guo, Q. (eds) Atlantoaxial Fixation Techniques. Translational Medicine Research. Springer, Singapore. https://doi.org/10.1007/978-981-10-7889-7_16
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DOI: https://doi.org/10.1007/978-981-10-7889-7_16
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