A formal methods approach to medical device review

@article{Jetley2006AFM,
  title={A formal methods approach to medical device review},
  author={Raoul Praful Jetley and S. Purushothaman Iyer and Paul L. Jones},
  journal={Computer},
  year={2006},
  volume={39},
  pages={61-67}
}
With software playing an increasingly important role in medical devices, regulatory agencies such as the US Food and Drug Administration need effective means for assuring that this software is safe and reliable. The FDA has been striving for a more rigorous engineering-based review strategy to provide this assurance. The use of mathematics-based techniques in the development of software might help accomplish this. However, the lack of standard architectures for medical device software and… CONTINUE READING

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