Abstract
Medical device software is usually embedded within the
overall system as one of the sub-systems. It needs to be
integrated with other sub-systems such as the electrical
and mechanical for a functional medical device to be
developed. In order to develop a working medical device
system through integrating its sub-systems, the
sub-systems' requirements have to be derived from the
overall medical device system requirements. The system
requirements are continuously collected, analysed and
built from the needs of different stakeholders such as
patients, health professionals and other companies
offering relevant devices, interfaces and software
related to the medical device system under development.
Various regulatory requirements have to be achieved for a
medical device to be allowed market access. We have
developed and piloted a medical device software process
assessment framework called MDevSPICEr that integrates
the regulatory requirements from the relevant medical
device software standards. This paper describes how the
MDevSPICEr framework has been designed to enable medical
device software developers to produce software that will
be safe and easily integrated with other sub-systems of
the overall medical device. We also describe the lessons
learned from piloting MDevSPICEr in the medical device
industry and introduce an agile methodology together with
its benefits and challenges. This paper outlines how
MDevSPICEr can be extended to include agile practices to
enable medical device software development to be
performed in a more flexible manner.
Original language | English |
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Pages (from-to) | 133-142 |
Journal | International Journal on Advances in Life Sciences |
Volume | 8 |
Issue number | 1-2 |
Publication status | Published - 2016 |
MoE publication type | A1 Journal article-refereed |
Keywords
- agile methods
- agile software development practices
- Mdevspicer
- medical device risks
- medical device software
- medical device software development