Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software-Reference-Cited by-同舟云学术

Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software

Published:2015 Issue: Volume: Page:19-30
ISSN:1865-0929
Container-title:Communications in Computer and Information Science
language:
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Author:

Rust Peter,Flood Derek,McCaffery Fergal

Publisher

Springer International Publishing

Link

http://link.springer.com/content/pdf/10.1007/978-3-319-19860-6_3

Reference26 articles.

1. Ward, J.R., Clarkson, P.J.: An analysis of medical device-related errors: prevalence and possible solutions. J. Med. Eng. Technol. 28(1), 2–21 (2004)

2. Alemzadeh, H., Iyer, R.K., Kalbarczyk, Z., Raman, J.: Analysis of Safety-Critical Computer Failures in Medical Devices. IEEE Secur. Priv. 11(4), 14–26 (2013)

3. ISO 13485:2003 - Medical devices – Quality management systems – Requirements for regulatory purposes. ISO, Geneva (2003)

4. ISO 14971:2007 - Medical devices – Application of risk management to medical devices. ISO, Geneva (2007)

5. IEC 62366-1:2007 - Medical devices – Part 1: Application of usability engineering to medical devices. ISO, Geneva (2007)

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. A Software Process Improvement Roadmap for IEC 62304: An Expert Review;Communications in Computer and Information Science;2018

2. Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304;Communications in Computer and Information Science;2016