Risk management of the new dynamic spinal stabilization system

Rong Fu Kuo, Cheng Jung Yang, Ruey Mo Lin, Chen Hsun Weng

研究成果: Conference contribution

摘要

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 manufacturer 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.

原文English
主出版物標題1st Global Conference on Biomedical Engineering and 9th Asian-Pacific Conference on Medical and Biological Engineering
編輯Fong-Chin Su, Ming-Long Yeh, Shyh-Hau Wang
發行者Springer Verlag
頁面216-219
頁數4
ISBN(電子)9783319122618
DOIs
出版狀態Published - 2015
事件1st Global Conference on Biomedical Engineering, GCBME 2014 and 9th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2014 - Tainan, Taiwan
持續時間: 2014 10月 92014 10月 12

出版系列

名字IFMBE Proceedings
47
ISSN(列印)1680-0737
ISSN(電子)1433-9277

Other

Other1st Global Conference on Biomedical Engineering, GCBME 2014 and 9th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2014
國家/地區Taiwan
城市Tainan
期間14-10-0914-10-12

All Science Journal Classification (ASJC) codes

  • 生物工程
  • 生物醫學工程

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