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Creation of an IEC 62304 compliant software development plan

Peter Rust, Derek Flood, Fergal McCaffery
2016 Journal of Software: Evolution and Process  
Organizations engaged in medical device software development are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed.  ...  One such standard IEC 62304, Medical device software -Software life-cycle processes, defines the processes that are required in order to develop safe software.  ...  The final template reflects the requirements of a software development plan for the medical device domain and by the addition of elements from current best practice, the template now comprises the following  ... 
doi:10.1002/smr.1826 fatcat:vtmmgjfnnnenfnuyn66byzoqhy

Datavision™ – What do medical writers need to know?

Russell Traynor, Thomas Gegeny
2014 Medical Writing  
Datavision™ is a publication planning software tool that is widely used across the healthcare industry to manage publication programmes.  ...  Within Datavision, a medical writer's activities will be focused on the Workbench to manage their assigned projects; the Journals, and Congress database to identify potential targets for discussion with  ...  Datavision is a software tool for publication planning and management that is used by more than 50 pharmaceutical, biotechnology, and device companies worldwide.  ... 
doi:10.1179/2047480613z.000000000182 fatcat:efavb6pf7vaxvas6ojsjqsjxiy

An Engineering Toolbox to Build Situation Aware Ambient Assisted Living Systems

Werner Kurschl, Stefan Mitsch, Johannes Schoenboeck
2008 2008 Third International Conference on Broadband Communications, Information Technology & Biomedical Applications  
The toolbox consists of a meta-model for pipeline systems, a low-level context model, high-level context ontologies, customizable components and tool support.  ...  In this paper we propose a reference architecture for building AAL systems. Based on this reference architecture we introduce a toolbox that simplifies the development of AAL systems.  ...  The code generator uses an instance of the meta-model and the template to generate source code for a specific platform.  ... 
doi:10.1109/broadcom.2008.36 dblp:conf/broadcom/KurschlMS08 fatcat:6qjj6kqyffgz5gwvractqzmfm4

Self-adaptive middleware for ubiquitous medical device integration

Andreas Kliem, Anett Boelke, Anne Grohnert, Nicolas Traeder
2014 2014 IEEE 16th International Conference on e-Health Networking, Applications and Services (Healthcom)  
We present a middleware solution for the integration of medical devices and the aggregation of resulting data streams, that is able to adapt itself to the requirements of patients and Care Delivery Operators  ...  Knowledge in the shape of configurations and runtime pluggable software modules is used to properly integrate and handle discovered medical devices on demand.  ...  Device Directory The Device Directory (DD) can be envisioned as a directory service for devices.  ... 
doi:10.1109/healthcom.2014.7001858 dblp:conf/healthcom/KliemBGT14 fatcat:ngn52wbhurg2dlgh2qop5fvkz4

Towards a Circular Economy via Intelligent Metamaterials [article]

Christos Liaskos, Ageliki Tsioliaridou, Sotiris Ioannidis
2018 arXiv   pre-print
The study begins by considering electromagnetic metamaterials, and proposes a complete methodology for their deployment.  ...  Intelligent metasurfaces can tune their physical properties (electromagnetic, acoustic, mechanical) by receiving software commands.  ...  ., a parameterized association between an objective template and a set of wireless emissions. We envision environment-wide policies, apart from device-specific objectives.  ... 
arXiv:1807.06006v1 fatcat:lr3svux27bbizivchpzniprkvq

Towards an AADL-Based Definition of App Architecture for Medical Application Platforms [chapter]

Sam Procter, John Hatcliff, Robby
2017 Lecture Notes in Computer Science  
There is a growing trend of developing software applications that integrate and coordinate the actions of medical devices.  ...  We present a tool prototype based on the OSATE2 distribution of the Eclipse IDE that targets the development of Medical Application Platform (MAP) apps.  ...  -Medical Device: Individual medical devices which will either be controlled by software components, or produce physiological information that will be consumed by software components.  ... 
doi:10.1007/978-3-319-63194-3_3 fatcat:acxatovqmngz5g72nuc5nqfpcm

Medical Student Appraisal

P. J. Sampognaro, S. L. Mitchell, S. R. Weeks, S. Khalifian, T. M. Markman, L. W. Uebel, J. R. Dattilo
2013 Applied Clinical Informatics  
Discussion: Mobile devices offer the potential to enhance pre-rounding efficiency for medical students and residents.  ...  The paper-based template was praised for its organization and familiarity amongst residents, but perceived as limited by the requirement of re-copying data into the hospital's electronic medical record  ...  Sampognaro et al.: Medical Student Appraisal: Electronic Resources for Inpatient Pre-Rounding  ... 
doi:10.4338/aci-2013-05-r-0032 pmid:24155792 pmcid:PMC3799210 fatcat:gbj3twov3fbgtpmsj55dx555ny

A template-based data specification framework for modeling physical security systems

Ashu Guru, Paul Savory
2006 Computers & industrial engineering  
This paper describes a template-based framework to help identify and specify the components and data parameters for developing models of physical security systems.  ...  Simulation studies often fail to provide any useful results due to its success being highly dependent on the skills of the analyst to understand a system and then correctly identify all the required data  ...  That is, they are specific to a simulation language, software program, and/or simulation package. For instance, several simulation software programs provide pre-defined A.  ... 
doi:10.1016/j.cie.2006.05.001 fatcat:nrcbtnv4zvefhdct3robp6fkcu

Platform for Automated Real-Time High Performance Analytics on Medical Image Data

William J. Allen, Refaat E. Gabr, Getaneh B. Tefera, Amol S. Pednekar, Matthew W. Vaughn, Ponnada A. Narayana
2018 IEEE journal of biomedical and health informatics  
Here, we demonstrate a robust platform that uses software automation and high performance computing (HPC) resources to achieve real-time analytics of clinical data, specifically magnetic resonance imaging  ...  We envision this platform can be adapted to other medical instruments, HPC resources, and analytics tools.  ...  Acknowledgments We thank Rion Dooley for helpful discussions and assistance with the Agave API, and Vipulkumar Patel for help with the MRI experiments.  ... 
doi:10.1109/jbhi.2017.2771299 pmid:29505399 pmcid:PMC5858700 fatcat:52gkcagynfgp3m4qeqleqjc63y

A Perspective on a Quality Management System for AI/ML-Based Clinical Decision Support in Hospital Care

Richard Bartels, Jeroen Dudink, Jeroen Dudink, Saskia Haitjema, Daniel Oberski, Annemarie van 't Veen, Annemarie van 't Veen
2022 Frontiers in Digital Health  
We finally envision a future in which healthcare institutions run or have access to a medical AI-lab that provides the necessary expertise and quality assurance for AI/ML-CDS implementation and applies  ...  Furthermore, we highlight the strong similarities between AI/ML-CDS models and in vitro diagnostic devices and propose to use ISO15189, the quality guideline for medical laboratories, as inspiration when  ...  with a data scientist who is aware of the medical domain and can assess the device for model performance and lifecycle-management requirements.  ... 
doi:10.3389/fdgth.2022.942588 pmid:35873347 pmcid:PMC9299425 doaj:c6cc683aac3141a088e1311d9bcc1d26 fatcat:wedko4aqkzd3zgoupnyxs4tb74

Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration

James E. Tcheng, Jay Crowley, Madris Tomes, Terrie L. Reed, Joseph M. Dudas, Kweli P. Thompson, Kirk N. Garratt, Joseph P. Drozda
2014 American Heart Journal  
Implementation of a UDI system for medical devices must anticipate both global and device-specific information. (Am Heart J 2014;168:405-413.e2.) From the  ...  In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements.  ...  Dr Drozda's son is a sales representative for Boston Scientific Corporation. All other authors have no relevant relationships with industry to declare.  ... 
doi:10.1016/j.ahj.2014.07.001 pmid:25262248 fatcat:avr75vxhvjdoxp6bn57fd76kmu

Using software engineering technology to improve the quality of medical processes

Lori A. Clarke, George A. Avrunin, Leon J. Osterweil
2008 Companion of the 13th international conference on Software engineering - ICSE Companion '08  
This work is still preliminary, but is suggesting new research directions for medical process improvement, software engineering technologies, and the applicability of these technologies to other domains  ...  We have been investigating the application of a continuous process improvement approach to medical processes in which detailed and semantically rich models of the medical processes are created and then  ...  Our project has been using specific software technologies to gain a deep understanding of medical processes and the nature of medical process improvement problems.  ... 
doi:10.1145/1370175.1370179 dblp:conf/icse/ClarkeAO08 fatcat:5z3rhkog2becnk3weqzr26zfxu

Service-Oriented Information Visualization for Smart Environments

Conrad Thiede, Christian Tominski, Heidrun Schumann
2009 2009 13th International Conference Information Visualisation  
To utilize such environments efficiently for information visualization, we propose a service-oriented architecture.  ...  We implemented a prototype that provides parallel coordinates, scatter plot matrices, and a map display.  ...  Acknowledgements The research presented in this paper is conducted within the graduate school "MuSAMA -Multimodal Smart Appliance Ensembles for Mobile Applications", which is funded by the Deutsche Forschungsgemeinschaft  ... 
doi:10.1109/iv.2009.54 dblp:conf/iv/ThiedeTS09 fatcat:pduj5lbg2nfahlehgiofhgz7xm

Nano Technology (A Microscopic Solution)

Govind Singh Tanwar, Ganesh Singh, Ravi Saharan
2010 International Journal of Computer Applications  
The current Nano Design software architecture is a set of C++ classes with a tcl front end for interactive molecular gear design.  ...  The objectives of this paper in Nano Technology are the design, modeling, and fabrication of molecular machines, molecular devices and software issues to design kind of devices and machine in Medical field  ...  As short lifetime medical nano-devices, they could be built to last only a few minutes in the body before falling apart into materials of the sort found in foods (such as fibre) 7 . 3) Medical nano-devices  ... 
doi:10.5120/506-823 fatcat:z2fpu3vuzbenvkkx6asba7jlcy

Opportunities and Challenges of Virtual Reality in Healthcare – A Domain Experts Inquiry

Andreas Halbig, Sooraj K. Babu, Shirin Gatter, Marc Erich Latoschik, Kirsten Brukamp, Sebastian von Mammen
2022 Frontiers in Virtual Reality  
The results show a generally positive attitude toward such a software platform. The users can imagine various use cases in different health domains.  ...  In particular, we conducted an online survey with 102 healthcare professionals based on a video prototype which demonstrates a software platform that allows them to create and utilise VR experiences on  ...  Therefore, when implementing the envisioned software platform, we should ensure that standard applications and templates are available to users.  ... 
doi:10.3389/frvir.2022.837616 fatcat:xxobzddzt5gwhe2sdaut5bzdha
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