Risk management of the new dynamic spinal stabilization system

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

Research output: Chapter in Book/Report/Conference proceedingConference contribution

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 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.

Original languageEnglish
Title of host publication1st Global Conference on Biomedical Engineering and 9th Asian-Pacific Conference on Medical and Biological Engineering
EditorsFong-Chin Su, Ming-Long Yeh, Shyh-Hau Wang
PublisherSpringer Verlag
Pages216-219
Number of pages4
ISBN (Electronic)9783319122618
Publication statusPublished - 2015 Jan 1
Event1st Global Conference on Biomedical Engineering, GCBME 2014 and 9th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2014 - Tainan, Taiwan
Duration: 2014 Oct 92014 Oct 12

Publication series

NameIFMBE Proceedings
Volume47
ISSN (Print)1680-0737
ISSN (Electronic)1433-9277

Other

Other1st Global Conference on Biomedical Engineering, GCBME 2014 and 9th Asian-Pacific Conference on Medical and Biological Engineering, APCMBE 2014
CountryTaiwan
CityTainan
Period14-10-0914-10-12

All Science Journal Classification (ASJC) codes

  • Bioengineering
  • Biomedical Engineering

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