- Software Verification and Validation, Software Testing, Distributed Computing, Web Services and SOA, Applied Mathematics, Software Engineering, and 9 moreSoftware Process Improvement and Assessment, Medical Device Design, Software Reengineering, University Assessment Practices, Thin Clients, App development, mHealth and eHealth, Android Vs Ios, and Swift Programmingedit
Research Interests: Engineering, Computer Science, Software Engineering, Lean Software Development, Medical Device Design, and 13 moreScience, Agile Methods (Software Engineering), Software, Methods, Scrum, Medical Device Software, Medical Device, Agile software development, Agile, Xp, Waterfall, Plan Driven, and Computer Sciences
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information... more
On 16 April 2011, the US Food and Drug Administration’s (FDA’s) final rule on medical device data systems (MDDSs) came into force. This rule attempts to remove the uncertainty surrounding the safety classification of certain information technology systems used in healthcare. Devices that now meet the criteria of being an MDDS are classified as Class I (general controls). However, this final ruling explicitly precludes specific software applications that meet the definition of an MDDS, such as electronic health record applications and computerised physician order entry applications, as being beyond the scope of an MDDS. Similarly, ambiguity still remains surrounding mobile device applications. The purpose of this article by Martin McHugh, Fergal McCaffery and Valentine Casey is to provide an overview of the FDA’s final rule on the safety classification of an MDDS, how this rule has been amended in comparison to the proposed rule and what this rule means for MDDS manufacturers. In add...
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Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well... more
Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration ( CMMI®). Copyright © 2006 Praise Worthy Prize - All rights reserved.
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0 7 4 0 7 4 5 9 / 0 7 / $ 2 0 . 0 0 © 2 0 0 7 I E E E Software process assessment remains the best way for an organization to begin an SPI program. Assessments can highlight strengths and weaknesses in an organization’s processes and... more
0 7 4 0 7 4 5 9 / 0 7 / $ 2 0 . 0 0 © 2 0 0 7 I E E E Software process assessment remains the best way for an organization to begin an SPI program. Assessments can highlight strengths and weaknesses in an organization’s processes and thereby focus the SPI effort. However, to deal with resource limitations, small software companies need short, light assessments. Furthermore, because SSCs are using agile methods widely, these agile approaches must be incorporated into any potential process assessment method. The Adept assessment method we’ve created takes into account the business realities facing SSCs. Adept combines the CMMI Class C appraisal guidelines3 and an adapted Agility/Discipline Assessment approach2,4 in a unified model. While we’ve generated promising results using each approach separately, our synthesis of these practices offers opportunities for real SPI gains in SSCs. Process improvement in small Irish software companies The Irish software industry is a key component of...
Research Interests: Computer Science, Agile Software Process Improvement, Medical Device Design, Software Development, Software, and 15 moreMedical devices, Iec, Medical Device Software, Medical Device Sofware Development, Medical Device Software development, Medical Device, FDA, Iso, Fda Regulations and Policies, Medical Software, Software Development Process, Food and Drug Administration, Regulated Software Development, FDA Guidline Documents, and FDA Approval
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peer-reviewed This paper provides an update on the development of a software process assessment and improvement model (Medi SPICE) specifically for the medical device industry. The development of Medi SPICE was launched at the SPICE 2009... more
peer-reviewed This paper provides an update on the development of a software process assessment and improvement model (Medi SPICE) specifically for the medical device industry. The development of Medi SPICE was launched at the SPICE 2009 Conference. Medi SPICE will consist of a Process Reference Model and a Process Assessment Model. The Medi SPICE Process Assessment Model will be used to perform conformant assessments of the software process capability of medical device suppliers in accordance with the requirements of ISO/IEC 15504-2: 2003. Some significant amendments have been made to the Medi SPICE architecture from what was proposed at the SPICE 2009 Conference. These amendments will be presented in this paper. SFI
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In this paper we describe the appraisal method that was developed by Lero (the Irish Software Engineering Research Centre) and Dundalk Institute of Technology (DkIT) to assess software processes within small to medium-sized Irish software... more
In this paper we describe the appraisal method that was developed by Lero (the Irish Software Engineering Research Centre) and Dundalk Institute of Technology (DkIT) to assess software processes within small to medium-sized Irish software organisations that have little or no experience of software process improvement (SPI) programmes. We developed a method, called Adept, through investigating the key factors that contribute to an effective software assessment method, reflecting the desires of Irish SMEs in terms of providing a “manageable” approach to SPI and through expanding upon the Express Process Appraisal (EPA) method [1] to fulfil these objectives.
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Research Interests: Engineering, Computer Science, Software Engineering, Project Management, Software Process Improvement and Assessment, and 15 moreMedical devices, Iec, Software Process Improvement, Medical Device Software, Medical Device Sofware Development, Medical Device Software development, Mdd, Medical Device Technology, FDA, Iso, Food and Drug Administration, Regulated Software Development, International Software Engineering Standards, Mission Critial Software Devellopmenbt, and European Medical Device Directicves
During the past 20 years Maturity & Capability Models (MCMs) become a buzzword in the ICT world. Since the initial Crosby’s idea in 1979, plenty of models have been created in the Software & Systems Engineering domains, addressing... more
During the past 20 years Maturity & Capability Models (MCMs) become a buzzword in the ICT world. Since the initial Crosby’s idea in 1979, plenty of models have been created in the Software & Systems Engineering domains, addressing various perspectives. By analyzing the content of the Process Reference Models (PRM) in many of them, it can be noticed that reuse-related issues have unfortunately often little importance in the appraisals of the capabilities of software organizations while in practice they are considered as significant contributors in traditional process and organizational performance appraisals. While MCMs represent a good mean for assessing the status of a set of processes, integrating two or more models with a common area of focus can offer more information and value for an organization. The aim of this paper is to present some information about Reuse best practices and models, keep the best components from each model and – using the LEGO (Living EnGineering prOcess) approach to process improvement - merge those best practices from several types of maturity models into an organizational Business Process Model (BPM) in order to achieve in an easier and faster way higher organizational maturity and capability levels.
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Research Interests: Computer Science, Software Engineering, Risk Management, Software Reliability, Software Design, and 11 moreSoftware Quality, Computer Software, Software Industry, Capability Maturity Model Integration, United States, Software Process Improvement, Medical Device, Capability Maturity Model, Boolean Satisfiability, Level, and Food and Drug Administration
Research Interests: Information Systems, Engineering, Computer Science, Software Engineering, Software Process Improvement and Assessment, and 12 moreSoftware Development, Software, Computer Software, Software Industry, Process Improvement, Design Process Model (Software engineering), Software Process Improvement, Agile software development, Personal Software Process, IEEE B.Tech Software Projects, Software Process, and Assessment Methods
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... Design Coding. Unit Testing. Maintenance. Anand Ramakrishnan [18] reports that such areas as system design and architecture, research and development outsourcing provide higher returns (up to 60%). ... Literature. [1]. N. Khan, WL... more
... Design Coding. Unit Testing. Maintenance. Anand Ramakrishnan [18] reports that such areas as system design and architecture, research and development outsourcing provide higher returns (up to 60%). ... Literature. [1]. N. Khan, WL Currie, V. Weerakkody, B. Desai, “Evaluating ...