The Development and Validation of a Roadmap for Traceability

Regan, Gilbert; Flood, Derek; McCaffery, Fergal

doi:10.1007/978-3-319-19860-6_5

Cited by 2 publications

(6 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…An overview of the approach used to develop the TAM and its structure is presented in Section 5.1. Further detail on the structure of the TAM can be obtained in the previous studies . Section 5.2 presents an overview of the approach used to develop the TR along with its structure.…”

Section: Traceabilitymentioning

confidence: 99%

“…Section 5.2 presents an overview of the approach used to develop the TR along with its structure. Further detail on the structure of the roadmap can be obtained in Regan et al Section 5.3 provides an outline of the approach used to validate the TAIF in addition to a summary of the findings from implementing the TAIF within 2 MD software organizations.…”

Section: Traceabilitymentioning

confidence: 99%

“…An initial validation of the TAIF was completed through expert review . Thirteen international experts in areas such as ISO/IEC 15504, MD software development and processes, MD software standards, traceability research and implementation, software process improvement, and roadmap development.…”

Section: Traceabilitymentioning

confidence: 99%

“…Further detail on the structure of the TAM can be obtained in the previous studies. 45,46 Section 5.2 presents an overview of the approach used to develop the TR along with its structure. Further detail on the structure of the roadmap can be obtained in Regan et al 46 Having decided to base the TAM on IS/IEC 15504, an approach to its development was formulated as depicted in Figure 2.…”

Section: Traceabilitymentioning

confidence: 99%

See 3 more Smart Citations

Mobile medical app development with a focus on traceability

Trektere

Regan

McCaffery

et al. 2017

J Software Evolu Process

Self Cite

View full text Add to dashboard Cite

Today, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device. Such applications have to be developed in compliance with medical device regulations. This can be a challenge for mobile medical application developers, as medical device software is normally developed in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability.

show abstract

Section: Traceabilitymentioning

confidence: 99%

Section: Traceabilitymentioning

confidence: 99%

Section: Traceabilitymentioning

confidence: 99%

Section: Traceabilitymentioning

confidence: 99%

See 2 more Smart Citations

Mobile medical app development with a focus on traceability

Trektere

Regan

McCaffery

et al. 2017

J Software Evolu Process

Self Cite

View full text Add to dashboard Cite

show abstract

“…The TAM identifies any gaps in an organizations implementation of traceability best practices [18] and/or medical device standards' traceability requirements [19], and the TR provides the pathway for an organization to plug those gaps. An initial validation of the TAIF was completed through expert review [15,16]. Further validation of the model has been completed through its implementation in two medical device organizations.…”

Section: Introductionmentioning

confidence: 99%

Research findings from an industrial trial of a traceability assessment and implementation framework

Regan¹,

Flood²,

McCaffery³

2016

Proceedings of the International Conference on Software and Systems Process

Self Cite

View full text Add to dashboard Cite

Software systems are becoming increasingly complex. Within safety critical domains such as medical device software, this increasing complexity is placing growing demands on manufacturers who must ensure their software not only meets functional requirements but is also safe and reliable. However, the Food and Drugs Administration who regulate medical device software in the United States report a significant increase in recalls between years 2003 and 2012 and have cited software difficulties as one of the frequent causes of recalls. Furthermore a recent analysis of traceability documentation submitted to the Administration has revealed that the traceability data was incomplete, incorrect, and conflicting in many cases. This is problematic as traceability plays an important role in the development of safe and reliable software. In this paper we present the validation, through industry trial, of a traceability assessment and implementation framework which we have developed to assist medical device organizations implement traceability in an efficient and regulatory compliant manner. Our findings show that implementation of the framework within two organizations improved their traceability process and that both organizations found the framework to be both useful and usable. CCS Concepts• Software and its engineering ~Traceability Software verification and validation

show abstract

The Development and Validation of a Roadmap for Traceability

Cited by 2 publications

References 19 publications

Mobile medical app development with a focus on traceability

Mobile medical app development with a focus on traceability

Research findings from an industrial trial of a traceability assessment and implementation framework

Contact Info

Product

Resources

About