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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… (More)
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Topic mentions per year

Topic mentions per year

2010-2016
02420102016

Related topics

Related topics

6 relations
Cantata++Development testingSoftware of unknown pedigreeTherac-25
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Broader (1)

Software development process

Related mentions per year

Related mentions per year

1942-2018
19401960198020002020
IEC 62304
Software development process
Therac-25
Software of unknown pedigree
Development testing
Time-triggered architecture

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
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… (More)
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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… (More)
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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… (More)
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2013
2013
Inomed Streamlines IEC 62304 Medical Device Software Certification
  • 2013
Inomed rapidly automated their established processes, enforced compliance with IEC 62034 coding standards, and introduced full… (More)
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2013
2013
Process of Designing Robust, Dependable, Safe and Secure Software for Medical Devices: Point of Care Testing Device as a Case Study
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
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… (More)
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2012
2012
Requirements specification for apps in medical application platforms
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
Standalone Software as an Active Medical Device
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
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… (More)
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2010
2010
Arguing for Software Quality in an IEC 62304 Compliant Development Process
 
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