Institutions
|
About Us
|
Help
|
Gaeilge
0
1000
Home
Browse
Advanced Search
Search History
Marked List
Statistics
A
A
A
Author(s)
Institution
Publication types
Funder
Year
Limited By:
Subject = software process improvement roadmaps;
3 items found
Sort by
Title
Author
Item type
Date
Institution
Peer review status
Language
Order
Ascending
Descending
25
50
100
per page
Bibtex
CSV
EndNote
RefWorks
RIS
XML
Displaying Results 1 - 3 of 3 on page 1 of 1
Marked
Mark
A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
A methodology for software process improvement roadmaps for regulated domains – example with IEC 62366
(2013)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine; Regan, Gilbert
Abstract:
Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives or-ganisations undergo an assessment and then embark on a software process im-provement program to improve their existing processes to meet a desired target. These programs can be improved by the use of process improvement roadmaps that are tailored to the organisation and are usually non-transferrable. Within regulated domains, such as the medical device industry, adherence to interna-tional standards must be achieved before products can be placed on the market. This work proposes the use of software process improvement roadmaps to assist organisations achieve compliance with medical device standards. These pro-posed roadmaps will be generic in nature to meet the requirements of the stand-ard, but will be subsequently tailored to meet the specific requirements of an individual organisation. In this paper we introduce the concept of the softwa...
http://hdl.handle.net/10344/3883
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
Marked
Mark
Understanding the relationships within the Medi SPICE framework
(2012)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine
Understanding the relationships within the Medi SPICE framework
(2012)
Flood, Derek; Mc Caffery, Fergal; Casey, Valentine
Abstract:
Regulated domains, such as medical device software development, require organisations to have specific processes in place in order to secure regulatory approval. Software process improvement initiatives, such as Medi SPICE, help organisations to improve their process in conformance with these regulations. These initiatives, however, do not specify how an organisation implements these processes, instead detailing what the organisation must implement. This work proposes the development of a series of roadmaps that will guide an organisation through the implementation of the required processes in a regulatory compliant manner. This paper presents the first step towards achieving this aim, which involves an investigation of the dependencies between the base practices defined in Medi SPICE in order to ensure that the produced roadmaps form a complete software development process in line with regulatory requirements. The paper describes two complementary approaches, a structured represent...
http://hdl.handle.net/10344/2793
Displaying Results 1 - 3 of 3 on page 1 of 1
Bibtex
CSV
EndNote
RefWorks
RIS
XML
Year
2016 (1)
2013 (1)
2012 (1)
built by Enovation Solutions