558 research outputs found
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Finding your Academic Voice: A Students Guide to the Art of Academic Writing
No full textThe ability to write in an academic style that is appropriate to the discipline is one of the most important skills that a student develops over the course of his or her studies. Academic writing can be a challenging endeavour and it is important to remember that it is a process that takes time, effort and feedback to master
Development of a process assessment model for assessing medical IT networks against IEC 80001-1
No full textIncreasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1
Barriers to using Agile Software Development Practices within the Medical Device Industry
Get PDFNon-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting Agile practices. Through a literature review this research identified the perceived barriers to ollowing agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine what the actual barriers are to adopting agile practices. In addition a comparison is performed between the perceived and actual barriers and the results are reported
Water is Life: Amazzi Bulamu project workshop - 8 Nov 2012
Get PDFThe Water is Life: Amazzi Bulamu project held its 2nd international workshop on 8th November 2012 in the Royal Irish Academy in Dublin.
The Water is Life Project is a partnership between a number of Higher Education Institutions and a range of key stakeholders. The PhD projects which are central to this project are all nearing completion so this workshop was an opportunity to hear about the research findings which are beginning to emerge in each project
The Barriers to Traceability and their Potential Solutions: Towards a Reference Framework
No full textTraceability of software artifacts, from requirements to design and through implementation and quality assurance, has long been promoted by the research and expert practitioner communities. However, evidence indicates that, with the exception of those operating in the safety critical domain, few software companies choose to implement traceability processes, often due to associated cost and complexity issues. This paper presents a review of traceability literature including the implementation of traceability in real organizations. Through both analyzing case studies and research published by leading traceability researchers, this paper synthesizes the barriers faced by organizations while implementing traceability, along with proposed solutions to the barriers. Additionally, given the importance of traceability in the regulated domain of safety critical software, the paper compares the barriers for organizations operating inside and outside of this domain
The Church of Ireland parochial associations: a social and cultural analysis
Get PDFa paper delivered to the 2007 conference at NUI Maynooth on the theme "Honouring God and community`; confraternities and sodalities in modern Ireland" and published in Colm Lennon (ed) Confraternities and Sodalities in Ireland charity, devotion and sociability (2012, Columba Press) Dublin, pp. 97-109
Changes to the International Regulatory Environment
No full textSince 2010, two significant international regulations regarding medical device development have come into force, the amendment to the European Union (EU) Medical Device Directive (MDD)
2007/47/EC and the United States (US) Food and Drug Administration (FDA) Final rule on Medical Device Data Systems (MDDS). Adherence to these regulations is mandatory to be able to market a medical device in the respective region. The ability to understand these regulations and apply them to a development project can be difficult. The MDDS final rule changes the safety classification of a number of devices from Class III‐high risk to Class I‐ low risk. The aim of this regulation is to make the process of achieving regulatory approval for manufacturers easier. The MDD aims to provide guidance for the development of medical devices to be marketed for use within the EU. It also
provides defined pathways which manufacturers can follow in order to achieve regulatory approval. However, changes made as part of amendment to the directive have a direct impact on the
development of medical devices. One of the most significant changes as part of this amendment is for software to potentially be considered as a medical device in its own right and potentially the only element in a medical device subject to regulatory conformance. These regulations have created confusion surrounding specific areas such as the use of mobile device applications for healthcare
purposes. This article describes the key points of these latest regulatory changes that medical device manufacturers need to be aware of
