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Framework Proposal Including HFE in Product Development Process: A Suitable Approach for the Brazilian Medical Equipment Industry

  • Ana Paula AlmeidaEmail author
  • Rodrigo Almeida
  • Renata Custódio
  • Clarissa Trzesniak
  • Carlos Mello
Conference paper
Part of the Advances in Intelligent Systems and Computing book series (AISC, volume 482)

Abstract

Brazilian Medical Industry is mostly comprised of small to medium-sized manufactures Small changes on requirements can pose a big challenge on their process. From December 2015 the IEC 60601-1-6 has become mandatory for all new medical equipment registration in Brazilian market. These two facts led to the development of this research, aimed at provide a framework to include HFE methods inside the product development process, while confirming with the standards. The framework should be simple to implement and provide practical information showing which tool to use at the right time, considering a device in development. The methods were selected based on previous Brazilian experiences and literature review. The final framework is constituted of 4 steps using 6 HFE methods, linked in such way that the information generated by one method can be used as input to the other method, minimizing work overhead, and documentation to the standard requirements.

Keywords

Human factors Usability Medical equipment Product development process 

Notes

Acknowledgments

The authors would like to acknowledge financial support of Capes, CNPq, Fapemig and Brazilian Health Ministry.

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Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • Ana Paula Almeida
    • 1
    Email author
  • Rodrigo Almeida
    • 1
  • Renata Custódio
    • 1
  • Clarissa Trzesniak
    • 1
  • Carlos Mello
    • 1
  1. 1.Universidade Federal de ItajubáItajubáBrazil

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