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Development of a process assessment model for medical device software development

Lepmets, Marion, Clarke, Paul, McCaffery, Fergal and Finnegan, Anita (2014) Development of a process assessment model for medical device software development. In: EuroSPI 2014, 25-27 Jun 2014, Luxembourg.

Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions (principally the EU and the US). In order to satisfy jurisdictional regulations, developers of medical device software generally implement standards and guidance provided by international standards bodies and national administrative departments. However, the various standards and guidance documents are not developed as a single cohesive set but often as separate re-sources addressing distinct areas of concern. The result for medical device software developers is that integration of these various sources represents a challenging undertaking. The aim of this paper is to describe the integration of the several process models and regulatory standards, first, into a process reference model and then into a process assessment model for medical device software development. The focus is on the integration of regulatory standards from the medical device domain with generic software development process models, resulting in a unified best practice framework for medical device software development. The process reference model for medical device software development is going to be published this year as IEC TR 80002-3, and the process assessment model for medical device software development is currently being validated through pilot studies in medical device industry. This best practice framework will help small software developers in their adoption of regulations-compliant best practices while reducing the overhead associated with understanding the long list of regulations and standards they need to adhere to when developing software for medical devices. This framework will also help the manufacturers in selecting their software suppliers assuring that the suppliers have adopted the best practices and are compliant with the medical device standards and regulations.
Item Type:Conference or Workshop Item (Paper)
Event Type:Conference
Uncontrolled Keywords:Process Assessment Model, Process Reference Model, Medical Device Software; Medical Device regulations; Best Practice Framework
Subjects:Computer Science > Software engineering
DCU Faculties and Centres:Research Institutes and Centres > Lero: The Irish Software Engineering Research Centre
Use License:This item is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 License. View License
ID Code:21086
Deposited On:05 Feb 2016 09:22 by Fran Callaghan . Last Modified 04 Feb 2020 15:38

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