Towards an Agile Development Model for Certifiable Medical Device Software - Taking Advantage of the Medical Device Regulation

Manuel Zamith, Gil Gonçalves

2018

Abstract

Regulation of medical devices has been one of the most prominent initiatives of the European Union in the health domain. The recent Medical Device Regulation 2017/745/EEC extended the definition of medical devices to standalone software systems with prognostic and prevision intended purposes. This paradigm shift stimulates the development of more lightweight software systems such as mobile applications, that can be classified as legitimate medical devices and can be prescribed to patients. This new context creates the need for an urgent adjustment of the currently used software development life cycle models and processes. This article discusses a tailored agile approach based on the Scrum model, designed to be compliant with the international standards for medical device software development and benefit the creation of software solutions according to the current Medical Device Framework. The discussion in this paper demonstrates there is no reason to believe that agile methodologies should not benefit the process of creating software solutions in the medical device domain.

Paper Citation

in Harvard Style

Gonçalves G. (2018). Towards an Agile Development Model for Certifiable Medical Device Software - Taking Advantage of the Medical Device Regulation.In Proceedings of the 13th International Conference on Software Technologies - Volume 1: ICSOFT, ISBN 978-989-758-320-9, pages 132-140. DOI: 10.5220/0006861301320140

in Bibtex Style

@conference{icsoft18,
author={Gil Gonçalves},
title={Towards an Agile Development Model for Certifiable Medical Device Software - Taking Advantage of the Medical Device Regulation},
booktitle={Proceedings of the 13th International Conference on Software Technologies - Volume 1: ICSOFT,},
year={2018},
pages={132-140},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0006861301320140},
isbn={978-989-758-320-9},
}

in EndNote Style

TY - CONF

JO - Proceedings of the 13th International Conference on Software Technologies - Volume 1: ICSOFT,
TI - Towards an Agile Development Model for Certifiable Medical Device Software - Taking Advantage of the Medical Device Regulation
SN - 978-989-758-320-9
AU - Gonçalves G.
PY - 2018
SP - 132
EP - 140
DO - 10.5220/0006861301320140