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IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements… Expand
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Cantata++Development testingSoftware of unknown pedigreeTherac-25
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Software development process

Papers overview

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2018
2018
IEC 62304: medical device software - software life-cycle processes
IEC 62304 is a framework of life-cycle processes, with activities and tasks, which focuses on the design and maintenance of safe… Expand
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Review
2018
Review
2018
A Software Process Improvement Roadmap for IEC 62304: An Expert Review
Manufacturers of medical devices must comply with certain legislation and regulations before they can market their products in… Expand
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Highly Cited
2017
Highly Cited
2017
Crisis management
 
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2016
2016
Software Process Improvement Roadmaps - Using Design Patterns to Aid SME's Developing Medical Device Software in the Implementation of IEC 62304
One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical… Expand
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Review
2016
Review
2016
Creation of an IEC 62304 compliant software development plan
Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device… Expand
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2015
2015
Software Process Improvement and Roadmapping - A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software
Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards… Expand
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2012
2012
Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304
The demand for medical device software continues to grow and there is an associated increase in its importance and complexity… Expand
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2011
2011
Implementation of IEC 62304 in Medical Device Software Development
It is required that IEC 62304-2006 Standard must be implemented during medical device certification since 2009.The implementation… Expand
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2010
2010
Arguing for Software Quality in an IEC 62304 Compliant Development Process
Safety regulations for medical device software are stipulated in numerous international standards. IEC 62304 addresses software… Expand
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2010
2010
Using Model-Based Design in an IEC 62304-Compliant Software Development Process
IEC 62304 [1] is an international standard (hereafter referred to as the Standard) that specifies software development life cycle… Expand
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