rian.ie - Browse

Author(s)
Institution
Publication types
Funder
Year

Limited By:	Author = Rust, Peter;

6 items found

Sort by

Order

per page

Displaying Results 1 - 6 of 6 on page 1 of 1

Marked Mark

A roadmap to ISO 14971 implementation (2015)

Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek

A roadmap to ISO 14971 implementation (2015)

Rust, Peter; McCaffery, Fergal; Casey, Valentine; McKeever, Ruth; Flood, Derek

Abstract:

Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap.

http://eprints.dkit.ie/547/

Marked Mark

A Software Process Improvement Roadmap for IEC 62304: an Expert Review (2018)

Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal

A Software Process Improvement Roadmap for IEC 62304: an Expert Review (2018)

Rust, Peter; Flood, Derek; Regan, Gilbert; McCaffery, Fergal

Abstract:

Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in the European Union (EU). The EU has introduced this legislation and regulation to provide the frameworks by which manufacturers can produce safe and effective medical devices in a consistent manner. The EU has accomplished this by way of Medical Device Directives and harmonised standards. Manufactures, by demonstrating compliance with a harmonised standard, can be presumed to have complied with the essential requirements of the legislation. IEC 62304 Medical device software – Software lifecycle processes is a harmonised standard. However, the standard provides no clear directions for meeting the requirements of the standard. A Software Process Improvement (SPI) Roadmap for IEC 62304:2006 has been developed as a method for aiding medical device software development organizations in implementing the standard. The Roadmap is divided into two levels, the high l...

http://eprints.dkit.ie/626/

Marked Mark

Creation of an IEC 62304 compliant Software Development Plan (2016)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Creation of an IEC 62304 compliant Software Development Plan (2016)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Abstract:

Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical Device Software—Software Life Cycle Processes, defines the processes that are required in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out but does not state how. In a review of a number of such organizations, it was found that the development of a software development plan proved to be a difficult task. In this work we have created a software development plan template to assist organizations with this arduous task. The software development plan template will be validated with these organizations as part of the future work.

http://eprints.dkit.ie/549/

Marked Mark

Software Process Improvement & Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software (2015)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Software Process Improvement & Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software (2015)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Abstract:

Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software -- Software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out, but does not state how. This paper presents a research method for generating a roadmap that will guide organizations in the implementation of IEC 62304.

http://eprints.dkit.ie/546/

Marked Mark

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304 (2015)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Software Process Improvement Roadmaps – Using Design Patterns to Aid SME’s Developing Medical Device Software in the Implementation of IEC 62304 (2015)

Rust, Peter; Flood, Derek; McCaffery, Fergal

Abstract:

One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical dev...

http://eprints.dkit.ie/548/

Marked Mark

Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304 (2016)

Rust, Peter; Flood, Derek; Mc Caffery, Fergal

Software process improvement roadmaps – using design patterns to aid SME’s developing medical device software in the implementation of IEC 62304 (2016)

Rust, Peter; Flood, Derek; Mc Caffery, Fergal

Abstract:

One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical device domain is one such domain identified by the EU. Medical device software development must be carried out in a manner that compliance with certain medical device standards and regulations can be demonstrated. IEC 62304, Medical device software - software life cycle processes, is a standard that defines the processes that are required to be executed in or-der to develop safe software. SME software development organizations wishing to expand their operations into the medical device software development domain face serious challenges in demonstrating compliance with IEC 62304. The standard describes the set of processes, activities, and tasks that are required to be carried out, but importantly do not describe how they should be carried out. This paper describes the development of a roadmap that will aid software development SME’s, entering the medical de...

http://hdl.handle.net/10344/5503

Displaying Results 1 - 6 of 6 on page 1 of 1