Book Chapters

McHugh, M., McCaffery, F., MacMahon, S. T. & Finnegan, A. (2013).
Improving Safety in Medical Devices from Concept to Retirements In:
Furht, B. & Agarwal, A. (eds.) Handbook of Medical and Healthcare
Technologies. Berlin: Springer-Verlag. DOI 10.1007/978-1-4614-8495-0_21

Journal Papers

McHugh, M., McCaffery, F., & Casey, V.(2013) Adopting Agile Practices
when developing software for use in the Medical Domain, Journal of
Software – Evolution and Process John Wiley & Sons DOI 10.1002/smr.1608

McHugh, M., McCaffery, F., & Casey, V. (2012) Changes to the
International Regulatory Environment, Journal of Medical Devices 6(2),
DOI 10.1115/1.4006592

McHugh, M., McCaffery, F., & Casey, V., (2012) Software Process
Improvement to assist Medical Device Software Development Organisations
to Comply with the amendments to the Medical Device Directive IET
Software Special Issue on European Software Process Improvement DOI
10.1049/iet-sen.2011.0198

McHugh, M., McCaffery, F. & Casey, V. (2011). US FDA releases final rule
on Medical Device Data Systems - What does this mean for device
manufacturers. Journal of Medical Device Regulation. 8(3), pp.35-40.
ISSN 1759-149X

Conference Papers

McHugh, M., McCaffery, F & Coady, G. (2014) Balancing Agility and
Discipline in a Medical Device Software Organisation, In The 14th
International SPICE Conference Process Improvement and Capability
dEtermination Vilnius Lithuania Springer 

McHugh, M., Ali, A.R and McCaffery, F. (2014) The Impact of Fuzzy
Requirements on Medical Device Software Development, in  European
Systems and Software Process Improvement and Innovation Conference
EuroSPI Luxembourg

McHugh, M., Cawley, O., McCaffery, F., Richardson, I. and Wang, X.
(2013) An Agile V-Model for Medical Device Software Development to
Overcome the Challenges with Plan Driven Software Development
Lifecycles, In The Software Engineering in Healthcare (SEHC) Workshop at
the 35th International Conference on Software Engineering (ICSE) San
Francisco, USA, IEEE

McHugh, M. and McCaffery, F. (2013) Challenges experienced by Medical
Device Software Organisations while following a Plan-driven Software
Development lifecycle In: European Systems and Software Process
Improvement and Innovation Conference EuroSPI Dundalk, Ireland

McHugh, M. Ali, AR and McCaffery, F. (2013) The Significance of
Requirements in Medical Device Software Development In: European Systems
and Software Process Improvement and Innovation Conference EuroSPI
Dundalk, Ireland

McHugh, M., McCaffery, F., Fitzgerald, B., Jan Stol, K., Casey, V. &
Coady, G. (2013) Balancing Agility and Discipline in a Medical Device
Software Organisation, In The 13th International SPICE Conference
Process Improvement and Capability dEtermination Bremen, Germany
Springer 10.1007/978-3-642-38833-0_18

McHugh, M., McCaffery, F., Casey, V. & Pikkarainen, M. (2012)
Integrating Agile Practices with a Medical Device Software Development
Lifecycle. In: European Systems and Software Process Improvement and
Innovation Conference, EuroSPI Vienna, Austria ISBN 978-87-7398-154-2

McHugh, M., McCaffery, F. & Casey, V. (2012) Barriers to using Agile
Software Development Practices within the Medical Device Industry. In:
European Systems and Software Process Improvement and Innovation
Conference, EuroSPI Vienna, Austria ISBN 978-87-7398-154-2

McHugh, M. (2012) Integrating Agile Practices with Plan-Driven Medical
Device Software Development In: The 13th International Conference on
Agile Software Development: XP 2012 Doctoral Symposium, Malmo Sweden May
21-25 ISBN 9781471778346

McHugh, M., McCaffery, F., & Casey, V. (2012) Barriers to Adopting Agile
Practices when Developing Medical Device Software In: The 12th
International SPICE Conference Process Improvement and Capability
dEtermination Majorca, Spain Springer pp. 141-147 DOI
10.1007/978-3-642-30439-2_13

McHugh, M., McCaffery, F. & Casey, V. (2011) Standalone Software as an
Active Medical Device In: The 11th International SPICE Conference
Process Improvement and Capability dEtermination Dublin, Ireland,
Springer, pp.97-107. DOI 10.1007/978-3-642-21233-8_9

McHugh, M., McCaffery, F. & Casey, V. (2011) How Amendments to the
Medical Device Directive affects the development of Medical Device
Software. In: European Systems and Software Process Improvement and
Innovation Conference, EuroSPI Roskilde, Denmark, pp. 2.1-2.8. ISBN
978-87-7398-153-5

McCaffery, F., Casey, V. & McHugh, M. (2011) How can software SMEs
become Medical Device SMEs. In: European Systems and Software Process
Improvement and Innovation Conference, EuroSPI Roskilde, Denmark.
Springer, pp.247-258 DOI 10.1007/978-3-642-22206-1_22

Poster Submissions

McHugh, M., McCaffery, F. & Casey, V. (2011) Using Software Process
Improvement to increase Patient Safety. In: SEPG Europe (Poster Session)
Dublin, Ireland. June 7-9

McHugh, M. (2012) Integrating Agile Practices with Plan-Driven Medical
Device Software Development In: The 13th International Conference on
Agile Software Development: XP 2012 (Poster Session) Malmo, Sweden. May
21-25

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