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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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2018
2018
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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2018
Review
2018
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
 
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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… Expand
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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… Expand
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2015
2015
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
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
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
Safety regulations for medical device software are stipulated in numerous international standards. IEC 62304 addresses software… Expand
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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… Expand
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