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Risk Management of the New Dynamic Spinal Stabilization System

  • Conference paper
1st Global Conference on Biomedical Engineering & 9th Asian-Pacific Conference on Medical and Biological Engineering

Part of the book series: IFMBE Proceedings ((IFMBE,volume 47))

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Abstract

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.

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Author information

Authors and Affiliations

  1. Medical Device Innovation Center, National Cheng Kung University, Tainan, Taiwan

    R. F. Kuo, C. J. Yang & C. H. Weng

  2. Orthopedics Department, National Cheng Jung University Hospital, Tainan, Taiwan

    R. M. Lin

Authors
  1. R. F. Kuo
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  2. C. J. Yang
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  3. R. M. Lin
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  4. C. H. Weng
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Editor information

Editors and Affiliations

  1. Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan

    Fong-Chin Su

  2. Department of Computer Science and Information Engineering, National Cheng Kung University, Tainan, Taiwan

    Shyh-Hau Wang

  3. Department of Biomedical Engineering, National Cheng Kung University, Tainan, Taiwan

    Ming-Long Yeh

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© 2015 Springer International Publishing Switzerland

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Kuo, R.F., Yang, C.J., Lin, R.M., Weng, C.H. (2015). Risk Management of the New Dynamic Spinal Stabilization System. In: Su, FC., Wang, SH., Yeh, ML. (eds) 1st Global Conference on Biomedical Engineering & 9th Asian-Pacific Conference on Medical and Biological Engineering. IFMBE Proceedings, vol 47. Springer, Cham. https://doi.org/10.1007/978-3-319-12262-5_60

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  • DOI: https://doi.org/10.1007/978-3-319-12262-5_60

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-12261-8

  • Online ISBN: 978-3-319-12262-5

  • eBook Packages: EngineeringEngineering (R0)

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