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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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Broader (1)

Software development process

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2019
2019
Building a Rule-Based Goal-Model from the IEC 62304 Standard for Medical Device Software
IEC 62304 is a standard for the medical device software lifecycle. Developers must develop software that complies with all… 
2017
2017
An evidence-based risk-oriented V-model methodology to develop ambient intelligent medical software
The Ambient Intelligence (AmI) paradigm has increasingly been adopted to build what we name Ambient Intelligent Medical Software… 
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… 
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… 
Review
2013
Review
2013
Taming complexity while gaining efficiency: Requirements for the next generation of test automation tools
The current product development environment for mechatronic systems is characterized by tight budgets, reduced development times… 
2012
2012
Requirements specification for apps in medical application platforms
Existing regulatory agency guidance documents and process standards for medical devices (i.e., IEC 62304) generally consider… 
2011
2011
Implementation of IEC 62304 in Medical Device Software Development
It is required that IEC 62304-2006 Standard must be implemented during medical device certification since 2009.The implementation… 
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… 
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… 
2010
2010
Formal methods in the development life cycle of real-time software
Preemptive Time Petri Nets (pTPNs) support modeling and analysis of concurrent timed software components running under fixed… 
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