IEC 62304

The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements… (More)
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Topic mentions per year

Topic mentions per year

2010-2016
02420102016

Papers overview

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Review
2016
Review
2016
Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device… (More)
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2016
2016
One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical… (More)
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2015
2015
Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards… (More)
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2013
2013
  • 2013
Inomed rapidly automated their established processes, enforced compliance with IEC 62034 coding standards, and introduced full… (More)
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2013
2013
This paper presents a holistic methodology for the design of medical device software, which encompasses a new way of eliciting… (More)
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2012
2012
The demand for medical device software continues to grow and there is an associated increase in its importance and complexity… (More)
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2012
2012
Existing regulatory agency guidance documents and process standards for medical devices (<i>i.e</i>., IEC 62304) generally… (More)
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Review
2011
Review
2011
With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active… (More)
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2010
2010
IEC 62304 [1] is an international standard (hereafter referred to as the Standard) that specifies software development life cycle… (More)
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