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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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Related topics

Related topics

6 relations
Cantata++Development testingSoftware of unknown pedigreeTherac-25

Broader (1)

Software development process

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
Review
2019
Review
2019
Applying ISO/IEC 29110 to ISO/IEC 62304 for Medical Device Software SME
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: 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… 
Highly Cited
2017
Highly Cited
2017
Crisis management
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… 
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… 
2015
2015
Framework for augmented reality in Minimally Invasive laparoscopic surgery
This article presents a framework for fusing preoperative data and intra-operative data for surgery guidance. This framework is… 
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… 
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… 
2011
2011
FPGA-Based Prototyping Methodology Manual: Best Practices in Design-For-Prototyping
This book collects the best practices FPGA-based Prototyping of SoC and ASIC devices into one place for the first time, drawing… 
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… 
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