Certification and regulatory challenges in medical device software development

2012 4th International Workshop on Software Engineering in Health Care (SEHC) ◽

10.1109/sehc.2012.6227011 ◽

2012 ◽

Author(s):

Nadica Hrgarek

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software ◽

Regulatory Challenges

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A hybrid assessment approach for medical device software development companies

Journal of Software Evolution and Process ◽

10.1002/smr.1929 ◽

2017 ◽

Vol 30 (7) ◽

pp. e1929

Author(s):

Özden Özcan-Top ◽

Fergal McCaffery

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software ◽

Assessment Approach

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Agile – Is it Suitable for Medical Device Software Development?

Communications in Computer and Information Science - Software Process Improvement and Capability Determination ◽

10.1007/978-3-319-38980-6_30 ◽

2016 ◽

pp. 417-422 ◽

Author(s):

Fergal McCaffery ◽

Kitija Trektere ◽

Ozden Ozcan-Top

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software

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High-Confidence Medical Device Software Development

Foundations and Trends® in Electronic Design Automation ◽

10.1561/1000000040 ◽

2015 ◽

Vol 9 (4) ◽

pp. 309-391 ◽

Author(s):

Zhihao Jiang ◽

Rahul Mangharam

Keyword(s):

Software Development ◽

Medical Device ◽

High Confidence ◽

Medical Device Software

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Managing requirements baselines for medical device software development

2012 IEEE International Systems Conference SysCon 2012 ◽

10.1109/syscon.2012.6189467 ◽

2012 ◽

Author(s):

Ken Wong ◽

Christine Callaghan

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software

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High-Confidence Medical Device Software Development

10.1561/9781680830699 ◽

2015 ◽

Author(s):

Zhihao Jiang ◽

Rahul Mangharam

Keyword(s):

Software Development ◽

Medical Device ◽

High Confidence ◽

Medical Device Software

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

Communications in Computer and Information Science - Software Process Improvement and Capability Determination ◽

10.1007/978-3-642-21233-8_8 ◽

2011 ◽

pp. 84-96 ◽

Author(s):

Oisín Cawley ◽

Ita Richardson ◽

Xiaofeng Wang

Keyword(s):

Software Development ◽

Medical Device ◽

Lean Manufacturing ◽

Manufacturing Plant ◽

Medical Device Software

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An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

2013 5th International Workshop on Software Engineering in Health Care (SEHC) ◽

10.1109/sehc.2013.6602471 ◽

2013 ◽

Author(s):

Martin Mc Hugh ◽

Oisin Cawley ◽

Fergal McCaffcry ◽

Ita Richardson ◽

Xiaofeng Wang

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software

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Meeting an End-user Need in a Collaborative High Risk Medical Device Software Development in Accordance with Future European Regulations

Proceedings of the 14th International Joint Conference on Biomedical Engineering Systems and Technologies ◽

10.5220/0010381502650273 ◽

2021 ◽

Author(s):

Stéphanie Py ◽

Thomas Lihoreau ◽

Marc Puyraveau ◽

Sylvain Grosdemouge ◽

Nadia Butterlin ◽

...

Keyword(s):

High Risk ◽

Software Development ◽

Medical Device ◽

End User ◽

Medical Device Software ◽

European Regulations ◽

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Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

IET Software ◽

10.1049/iet-sen.2011.0198 ◽

2012 ◽

Vol 6 (5) ◽

pp. 431 ◽

Author(s):

M. McHugh ◽

F. McCaffery ◽

V. Casey

Keyword(s):

Software Development ◽

Medical Device ◽

Process Improvement ◽

Software Process ◽

Software Process Improvement ◽

Medical Device Software

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Research on Medical Device Software Development and Design Based on CMMI Model

International Journal Bioautomation ◽

10.7546/ijba.2019.23.4.000625 ◽

2019 ◽

Vol 23 (4) ◽

pp. 469-478

Author(s):

Yang Tang ◽

Keyword(s):

Software Development ◽

Medical Device ◽

Medical Device Software

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