Managing requirements baselines for medical device software development

Wong, Kenneth; Callaghan, Christine

doi:10.1109/syscon.2012.6189467

Cited by 2 publications

(2 citation statements)

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“…McHugh et al (2012) identified how regulations affect medical device software development companies, and they made recommendations on compliance with IEC 62304. Wong and Callaghan (2012) described an approach taken to manage the baselines of software requirements for medical devices in need of compliance with IEC 62304.…”

Section: Resultsmentioning

confidence: 99%

Fundamentos do IEC 62304 com um Modelo Ágil de Desenvolvimento de Software

Marques¹,

Barros²,

Yelisetty³

et al. 2021

Minicursos Do SBCAS 2021

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In 2006, a working group from the International Electrotechnical Commission (IEC) defined IEC 62304:2006. Thus, the use of IEC 62304 has become fully harmonized in the United States and Europe. The purpose of IEC 62304 is to provide requirements for Healthcare Systems manufacturers with Software to demonstrate their ability to provide Software that consistently meets customer requirements and applicable regulatory requirements. Objective: This chapter aims to present the fundamentals of IEC 62304 with an Agile Software Development Model. Justification and motivation: In 2021, IEC 62304 completes 15 years. Thus, the authors believe that there are already works that report experiences, analyzes and difficulties in its use. These results can be interesting to direct further research and definitions of methods, models, guides or other materials to comply with IEC 62304. Conclusion: This book chapter provided a lecture with fundamentals of IEC 62304, including an Agile Software Development Model.

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Section: Resultsmentioning

confidence: 99%

Fundamentos do IEC 62304 com um Modelo Ágil de Desenvolvimento de Software

Marques¹,

Barros²,

Yelisetty³

et al. 2021

Minicursos Do SBCAS 2021

View full text Add to dashboard Cite

show abstract

“…Some authors have addressed this issue proposing a Risk Management Capability Model based on SPI (Software Process Improve-ment) techniques [2] or mapping quality system requirements with Capability Maturity Model Integration (CMMI) [3 -5]. Other authors have contributed to the analysis of the organisation's risk management process providing case studies related to a specific environment [6 -8], or focusing on the process necessary to identify residual risks [9] or to manage off-the-shelf [10] or mobile MD software [11]. It should be noted that while there is an extensive literature on software development [12] that includes project risk management process [13,14], research studies focused on the MD domain are not so diffused [15].…”

Section: Introductionmentioning

confidence: 99%

The Integration of the Risk Management Process with the Lifecycle of Medical Device Software

Pecoraro

Luzi²

2014

Methods Inf Med

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Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

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Managing requirements baselines for medical device software development

Cited by 2 publications

References 1 publication

Fundamentos do IEC 62304 com um Modelo Ágil de Desenvolvimento de Software

Fundamentos do IEC 62304 com um Modelo Ágil de Desenvolvimento de Software

The Integration of the Risk Management Process with the Lifecycle of Medical Device Software

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