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Investigation of Traceability within a Medical Device Organization [chapter]

Gilbert Regan, Fergal McCaffery, Kevin McDaid, Derek Flood
2013 Communications in Computer and Information Science  
Through interviews with a medical device SME, this paper seeks to determine how traceability is implemented within the organization, the difficulties it faces in implementing traceability, how compliant  ...  Organizations operating within the safety critical domains are mandated to implement traceability, and find the implementation and maintenance of an efficient and compliant traceability process a difficult  ...  The aim of our case study was to answer the following research questions: 1. What is the traceability practice within a medical device SME? 2.  ... 
doi:10.1007/978-3-642-38833-0_19 fatcat:fldo2jfcovg4rodd5axwvfs2dm

New EMPIR project Metrology for Drug Delivery , the role of IPQ

Elsa Batista, Maria Do Céu Ferreira, Andreia Furtado, João Alves E Sousa
2019 Zenodo  
of existing drug delivery devices (and other medical devices, like infusion pumps analysers) and inline sensors that work at a flow rate lower than 100 nL/min, in order to prevent inaccurate measurement  ...  It involves 15 participants from National and Designated Metrology Institutes, Companies, Hospitals and Academia and has the main objective of enabling traceable measurements of volume, flow and pressure  ...  ACKNOWLEDGMENT The EMPIR project "MeDDII" is carried out with funding of European Union under the EMPIR.  ... 
doi:10.5281/zenodo.3628228 fatcat:jezt4mvn4bgvvgbmn6ymv3uyxa

Mobile medical app development with a focus on traceability

Kitija Trektere, Gilbert Regan, Fergal Mc Caffery, Derek Flood, Marion Lepmets, Grainne Barry
2017 Journal of Software: Evolution and Process  
We detail one of the key criteria for mobile medical application development framework -traceability.  ...  When it comes to mobile medical apps, developers need to understand what is required when a mobile application fulfils the definition of a medical device.  ...  Medical Device Software Regulations Within the safety-critical domains it is important to have a Quality Management System (QMS) in place.  ... 
doi:10.1002/smr.1861 fatcat:dqanno6vcvgknoqz77oy2sy72m

Design of traceability system for medical devices based on blockchain

Xiaoling Xia, Xiaolin Lin, Wenbin Dong, Zhi He
2019 Journal of Physics, Conference Series  
Aiming at the centralization problem of the traditional medical device traceability system. This paper proposes a medical device traceability system based on blockchain technology.  ...  the traceability of the production, sales and use of medical devices.  ...  A perfect medical device traceability system can improve the brand reputation of enterprises, control the quality and safety of medical devices, and facilitate the rapid and accurate recall of problem  ... 
doi:10.1088/1742-6596/1314/1/012067 fatcat:rcqgkksufvhs5he4bkfgalkomq

A Traceability Process Assessment Model for the Medical Device Domain [chapter]

Gilbert Regan, Miklos Biro, Fergal Mc Caffery, Kevin Mc Daid, Derek Flood
2014 Communications in Computer and Information Science  
To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the development of a traceability process assessment model  ...  Within the medical device domain, as in other safety critical domains, software must provide reliability, safety and security because failure to do so can lead to injury or death.  ...  of this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero -the Irish Software  ... 
doi:10.1007/978-3-662-43896-1_18 fatcat:z52zncsehffvvbsrtrcswfdvfy

Advanced Medical Devices for Preparation and Administration of Chemotherapeutic Agents: Results from a Multi-Dimensional Evaluation

Lucrezia Ferrario, Fabrizio Schettini, Elisabetta Garagiola, Adriana Cecchi, Lucia Lugoboni, Paolo Serra, Emanuele Porazzi, Emanuela Foglia
2020 ClinicoEconomics and Outcomes Research  
The implementation of closed systems, integrated with a traceable workflow grounding on gravimetric control, may be considered a valid technological alternative within the investigated setting.  ...  To evaluate the incremental benefits concerning the implementation of closed-system medical devices for the preparation and administration of chemotherapy agents (integrated or not with traceable workflow  ...  Acknowledgments The authors would like to thank all the professionals involved, for their valuable support to complete the qualitative and quantitative questionnaires, leading to the success of the present  ... 
doi:10.2147/ceor.s267283 pmid:33293839 pmcid:PMC7718866 fatcat:75igsfsgv5bj3in4vrgzwi5zdy

New EMPIR project – Metrology for Drug Delivery

E. Batista, A. Furtado, J. Pereira, M. Ferreira, H. Bissig, E. Graham, A. Niemann, A. Timmerman, J. Alves e Sousa, F. Ogheard, A.W. Boudaoud
2020 Flow Measurement and Instrumentation  
The main objective is to enable traceable measurements of volume, flow and pressure of existing drug delivery devices (like infusion pumps and analysers) and inline sensors that work at flow rates lower  ...  A B S T R A C T This document presents the scientific and technical objectives, state of the art and expected progress beyond it, and most importantly the expected impact on metrology, science, standards  ...  Acknowledgment The EMPIR project "MeDDII" is carried out with funding of European Union under the EMPIR.  ... 
doi:10.1016/j.flowmeasinst.2020.101716 fatcat:77olpifu3bdazd6dc3dymqbsju

Barriers to Adopting Agile Practices When Developing Medical Device Software [chapter]

Martin McHugh, Fergal McCaffery, Valentine Casey
2012 Communications in Computer and Information Science  
However, software developed for use in medical devices must be regulatory compliant and this can make the process of following a single agile methodology such as XP difficult to achieve.  ...  This paper outlines how we identified the barriers to agile adoption in the medical device software domain through performing a survey.  ...  /I2030 (the funding of this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero  ... 
doi:10.1007/978-3-642-30439-2_13 fatcat:epoceugdpne5bhn3nv6oo25c34

The role of metrology in the field of medical devices

M. do Céu Ferreira
2011 International Journal of Metrology and Quality Engineering  
in the framework of the medical devices regulation with a measuring function.  ...  This paper focuses on the use of medical devices looking to enhance its metrological traceability, highlighting the specific role of metrology in the field of health care and the impact of legal control  ...  Cartaxo Reis (director of legal metrology unit of IPQ) for his contribution to the revision paper.  ... 
doi:10.1051/ijmqe/2011101 fatcat:atlk7i35b5hwlafswe5hzve72i

Traceability-Why Do It? [chapter]

Gilbert Regan, Fergal McCaffery, Kevin McDaid, Derek Flood
2012 Communications in Computer and Information Science  
This paper presents a review of traceability literature including the implementation of traceability in real organizations.  ...  Through both analyzing case studies and research published by leading traceability researchers, this paper synthesizes the motivations of the organizations for implementing traceability.  ...  /I2030 (the funding of this project was awarded by Science Foundation Ireland under a co-funding initiative by the Irish Government and European Regional Development Fund), and supported in part by Lero  ... 
doi:10.1007/978-3-642-30439-2_15 fatcat:ypolvoyepbcztcvwa2n635skeq

Barriers and Opportunities in Recalls Management at the Health Care Provider level

Angélica Burbano Collazos, José Antonio García Pretelt, Luisa Fernanda Durán Gutiérrez, Diego Mauricio Ojeda Navia
2017 Revista Ingeniería Biomédica  
One of the operational risks to which a Health Care Provider (HCP) is exposed is the receiving and use of products such as pharmaceuticals and medical devices that could become subject to a health alert  ...  This article aims to expose a characterization of the alerts response process at the HCP level based on a review of the literature.  ...  About pharmaceuticals and medical devices traceability, two scenarios were identified.  ... 
doi:10.24050/19099762.n22.2017.1180 fatcat:mwkfzp7sofd5zfiwywjx4v3nlq

The Impact of Regulatory Compliance on Agile Software Processes with a Focus on the FDA Guidelines for Medical Device Software

Hossein Mehrfard, Abdelwahab Hamou-Lhadj
2011 International Journal of Information System Modeling and Design  
Our findings show that XP fails to meet many of the FDA guidelines for medical device software, which increases the risks of non-compliance for organizations that have adopted XP as their main software  ...  The difficulty of complying with different regulations has become more evident as a large number of regulated businesses are mandated to follow an ever-increasing set of regulations.  ...  We particularly looked into the requirements imposed by the FDA on the way medical device software is built, tested, and maintained.  ... 
doi:10.4018/jismd.2011040104 fatcat:o3fv7jq4kzawfcvo37stosx53i

Challenges of Agile Practices Implementation in the Medical Device Software Development Methodologies

Miloš D. Kostić
2017 European Project Management Journal  
Medical Device industry is facing new challenges as software is taking a more dominant role and the established development methodologies are struggling to meet the growing demand for rapidly produced  ...  This paper presents review of the available literature on the subject of introducing the Agile practices in the Medical device industry with the aim to systematically point out the advantages, challenges  ...  This however may pose a challenge for many organizations.  ... 
doaj:8fc76fa085744f85a08a6f08bfdcd7f3 fatcat:rts4mg4v2ncntbfp7voyeicif4

Implementing Radio Frequency Identification within the Perioperative Process: A Case Study Perspective

James Ryan, Barbara Doster, Sandra Daily, Carmen Lewis, Rosemary Glass
2012 Americas Conference on Information Systems  
Based on an 87-month longitudinal study of a large 909 registered-bed teaching hospital, this paper investigates the complexity of technological change dynamics, integrated information systems, as well  ...  As a technology solution, radio frequency identification (RFID) has proven increased efficiency and accuracy within traditional production and inventory control environments.  ...  POC also requires high validity as to the contextual location of the individual medical devices within a defined proximity.  ... 
dblp:conf/amcis/RyanDDLG12 fatcat:gdanh4aadvhb5osfunl7fjtic4

Traceability in healthcare: crossing boundaries

C Lovis
2008 IMIA Yearbook of Medical Informatics  
Traceability is a major aspect of the future in healthcare and requires the attention of the community of medical informatics.  ...  Traceability is also increasingly seen as a mean to improve efficiency of the logistics of care and a way to better understand costs and usage of resources.  ...  A few only are devoted to non-human tissues or goods traceability, such as drugs, implants or devices; almost none address the problem of supply chain traceability in healthcare and logistics.  ... 
pmid:18660885 fatcat:yg4trtal2zgnncghhtya5ktopa
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