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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… 
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Papers overview

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Review
2019
Review
2019
Medical Device (MD) and Medical Device Software (MDS) imperatively precise as they are dealing with human life and human health… 
Highly Cited
2018
Highly Cited
2018
IEC 62304 is a framework of life-cycle processes, with activities and tasks, which focuses on the design and maintenance of safe… 
Highly Cited
2017
Highly Cited
2017
Review
2016
Review
2016
Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device… 
2016
2016
One stated objective of the European Union is to encourage SME’s expand their area of operation into other domains. The medical… 
2015
2015
This article presents a framework for fusing preoperative data and intra-operative data for surgery guidance. This framework is… 
2015
2015
Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards… 
2012
2012
The demand for medical device software continues to grow and there is an associated increase in its importance and complexity… 
2011
2011
This book collects the best practices FPGA-based Prototyping of SoC and ASIC devices into one place for the first time, drawing… 
2010
2010
Safety regulations for medical device software are stipulated in numerous international standards. IEC 62304 addresses software…