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Published in:
2015 | OriginalPaper | Chapter
Risk Management of the New Dynamic Spinal Stabilization System
Authors : R. F. Kuo, C. J. Yang, R. M. Lin, C. H. Weng
Published in: 1st Global Conference on Biomedical Engineering & 9th Asian-Pacific Conference on Medical and Biological Engineering
Publisher: Springer International Publishing
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A risk management report is an important part of the technical documentation of any medical device since it contains the risks and hazards linked to use and how the man-ufacturer handled them for the purposes of performance and safety. For devices sold in Europe, EN ISO 14971 provides methods and tools for manufacturers to analyze and manage the risks associated with their devices. This study analyzes a new dynamic spinal stabilization system based on ISO 14971 to optimize the performances and safety of the new design.