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Medical Device Software Development - A Perspective from a Lean Manufacturing Plant

  • Oisín Cawley
  • Ita Richardson
  • Xiaofeng Wang
Conference paper
Part of the Communications in Computer and Information Science book series (CCIS, volume 155)

Abstract

Developing software for the manufacture of medical devices is a sensitive operation from many perspectives, such as: safety and regulatory compliance. Medical Device companies are required to have a well defined development process in place, which includes software development, and be able to demonstrate that they have followed it through the complete life-cycle of the device. With the increasing complexity of Medical Devices, and more detailed software development regulations among some of the influencing factors, we take a look at how some of these factors have impacted the software development process within a medical device manufacturing plant. We find that tying down your process across the board can have unwanted consequences. As process flexibility is required, we have investigated the usefulness of Lean Software Development.

Keywords

Software Development Process Medical Device Regulated Environment Process Improvement Lean Software Development 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2011

Authors and Affiliations

  • Oisín Cawley
    • 1
  • Ita Richardson
    • 1
  • Xiaofeng Wang
    • 1
  1. 1.Lero - the Irish Software Engineering Research CentreUniversity of LimerickIreland

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