The Experts below are selected from a list of 282678 Experts worldwide ranked by ideXlab platform
F G Wilkie - One of the best experts on this subject based on the ideXlab platform.
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risk management process improvement for the medical device industry
International Conference on Software Development, 2005Co-Authors: Fergal Mccaffery, D Mcfall, Peter Donnelly, F G WilkieAbstract:This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [4] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (CE marking requirement) is achieved. Integrated into the Design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a Design History file. Design History illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
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a software process development assessment and improvement framework for the medical device industry
2004Co-Authors: Fergal Mccaffery, Peter Donnelly, Alec Dorling, F G WilkieAbstract:This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved. Integrated into the Design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a Design History file. Design History illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
Konvalinková Pavla - One of the best experts on this subject based on the ideXlab platform.
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Transfermoral amputation and knee joint disarticulation, rehabilitation procedure after lower limb amputation
2021Co-Authors: Konvalinková PavlaAbstract:BACHELOR THESIS ABSTRACT Author: Pavla Konvalinková Supervisor: Ing. Adéla Slámová Tutor: Hana Kohoutová, DiS Title: Transfemoral amputation and knee joint disarticulation Subtitle: Rehabilitation procedure after lower limb amputation Abstract: This bachelor thesis deals with the issue of transfemoral amputations and exarticulations in the knee joint and the possibilities of rehabilitation care for patients after amputation of the lower limb. The work will offer both an earlier and a current view of the issue from the position of a doctor, prosthetist and physiotherapist. The work is divided into theoretical and practical part. In the introductory theoretical part, circulatory techniques are described in detail in terms of indications, Design, History, advantages and disadvantages and possibilities of prosthetic equipment. Further work summarizes the knowledge about the possibilities of physiotherapeutic intervention from preoperative and postoperative care to equipping the patient with a prosthetic device. In the second practical part, two case reports of patients with selected two procedures are processed. The aim of the work is to bring the known knowledge on the issue of transfemoral amputations and exarticulations in the knee joint and then apply this knowledge and selected procedures in clinical..
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Transfermoral amputation and knee joint disarticulation, rehabilitation procedure after lower limb amputation
Univerzita Karlova 1. lékařská fakulta, 2021Co-Authors: Konvalinková PavlaAbstract:BAKALÁŘSKÉ PRÁCE Jméno, příjmení: Pavla Konvalinková Vedoucí práce: Ing. Adéla Slámová Konzultant práce: Hana Kohoutová, DiS. Název bakalářské práce: Transfemorální amputace a exartikulace kolenního kloubu Podnázev: Rehabilitační postup po amputaci dolní končetiny Abstrakt bakalářské práce: Tato bakalářská práce se zabývá problematikou transfemorálních amputací a exartikulací v kolenním kloubu a možnostmi rehabilitační péče u pacientů po amputaci dolní končetiny. Práce nabídne jak dřívější, tak současný pohled na danou problematiku z pozice lékaře, protetika i fyzioterapeuta. Práce je rozdělená na část teoretickou a praktickou. V úvodní teoretické části jsou obě techniky podrobně popsány z hlediska indikací, provedení, historie, výhod i nevýhod a možností protetického vybavení. Dále práce shrnuje poznatky o možnostech fyzioterapeutické intervence od předoperační a časné pooperační péče až po vybavení pacienta protetickou pomůckou. Ve druhé praktické části jsou zpracované dvě kazuistiky pacientů s vybranými dvěma zákroky. Cílem práce je přinést dosud známé poznatky k problematice transfemorálních amputací a exartikulací v kolenním kloubu a následně tyto poznatky a vybrané postupy aplikovat v klinické praxi a zhodnotit efekt terapie. Dílčím cílem práce je sestavení brožury s kondičními cviky. Klíčová...BACHELOR THESIS ABSTRACT Author: Pavla Konvalinková Supervisor: Ing. Adéla Slámová Tutor: Hana Kohoutová, DiS Title: Transfemoral amputation and knee joint disarticulation Subtitle: Rehabilitation procedure after lower limb amputation Abstract: This bachelor thesis deals with the issue of transfemoral amputations and exarticulations in the knee joint and the possibilities of rehabilitation care for patients after amputation of the lower limb. The work will offer both an earlier and a current view of the issue from the position of a doctor, prosthetist and physiotherapist. The work is divided into theoretical and practical part. In the introductory theoretical part, circulatory techniques are described in detail in terms of indications, Design, History, advantages and disadvantages and possibilities of prosthetic equipment. Further work summarizes the knowledge about the possibilities of physiotherapeutic intervention from preoperative and postoperative care to equipping the patient with a prosthetic device. In the second practical part, two case reports of patients with selected two procedures are processed. The aim of the work is to bring the known knowledge on the issue of transfemoral amputations and exarticulations in the knee joint and then apply this knowledge and selected procedures in clinical...Department of Rehabilitation Medicine First Faculty of Medicine and General University HospitalKlinika rehabilitačního lékařství 1. LF UK a VFN1. lékařská fakultaFirst Faculty of Medicin
Fergal Mccaffery - One of the best experts on this subject based on the ideXlab platform.
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risk management process improvement for the medical device industry
International Conference on Software Development, 2005Co-Authors: Fergal Mccaffery, D Mcfall, Peter Donnelly, F G WilkieAbstract:This paper outlines a software process improvement (SPI) framework to ensure regulatory compliance for the software developed in medical devices. The software framework introduced here (known as MedeSPI – Medical Devices Software Process Improvement) will address an opportunity to integrate the regulatory issues and process improvement mechanisms in order to achieve improved software processes within a number of process areas that are critical to the development of software for medical devices [3]. The paper then describes in detail how the goals, practices and capability levels for the risk management process area within the MedeSPI framework have been developed. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [4] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (CE marking requirement) is achieved. Integrated into the Design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a Design History file. Design History illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
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a software process development assessment and improvement framework for the medical device industry
2004Co-Authors: Fergal Mccaffery, Peter Donnelly, Alec Dorling, F G WilkieAbstract:This paper describes a software process development, assessment and improvement framework, structured to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (US requirement), and the European Commission under its Medical Device Directives (CE marking requirement) is achieved. Integrated into the Design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a Design History file. Design History illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.
Global Risd - One of the best experts on this subject based on the ideXlab platform.
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Victor Papanek: Design, Ecology, and Global Activism | Alison Clarke
DigitalCommons@RISD, 2018Co-Authors: Division, Liberal Arts, Department, Theory History Of Art & & Design, Museum Risd, Global RisdAbstract:VIEW EVENT PHOTOS Lecture, October 4, 2018. 6:00 pm Metcalf Auditorium, RISD Museum/Chace Center. The division of Liberal Arts, THAD department and RISD Museum welcome author and Design historian Alison Clarke to RISD to give a lecture titled “Victor Papanek: Design, Ecology and Global Activism. In 1968, Papanek described the Design profession as a mode of “do-it-yourself murder” that generates waste, wreaks ecological havoc and excludes the most socially disadvantaged. Design, he warned, had become preoccupied with “the concocting of such inane trivia as mink-covered toilet-seats, electronic fingernail polish dryers and baroque fly-swatters,” rather than solving “real world” needs. Based on the forthcoming book Victor Papanek: Designer for the Real World (MIT Press) and research for a recent co-curated exhibition with the Vitra Design Museum, Germany, the lecture will explore how Papanek’s iconoclastic Designs, provocative journalism and unique global pedagogic initiatives upended the complacency of the 1960s and ’70s Design establishment. Clarke will examine how this shift in the perception of Design as a political tool was part of a broader challenge to commodity culture that drew on feminist and counter-culture ideas of non-capitalist production, African-American civil rights and global post-colonial activism, and a burgeoning ecological movement. She will conclude by examining the legacy of Papanek’s ideas in contemporary Design discourse. This event is sponsored by the Division of Liberal Arts graduate programs in Global Arts and Cultures and Nature-Culture-Sustainability Studies in conjunction with the RISD Museum’s Repair and Design Futures Exhibition and RISD Global. Alison J. Clarke is a Design historian and trained social anthropologist. She is chair of Design History and Theory and Director of the Victor J. Papanek Foundation, University of Applied Arts Vienna, and taught previously at the Royal College of Art, London. Professor Clarke’s publications include Tupperware: The Promise of Plastic in 1950s America, which became the basis of an Emmy Award nominated PBS documentary, Design Anthropology: Object Culture in the 21st Century (2017), and Émigré Cultures in Design and Architecture (with Elana Shapira, 2017). She is currently completing a monograph for MIT Press titled Victor Papanek: Designer for the Real World, as well as co-curating a related exhibition at the Vitra Design Museum, Germany.https://digitalcommons.risd.edu/liberalarts_ncss_events/1004/thumbnail.jp
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Victor Papanek: Design, Ecology, and Global Activism | Alison Clarke
DigitalCommons@RISD, 2018Co-Authors: Division, Liberal Arts, Department, Theory History Of Art & & Design, Museum Risd, Global RisdAbstract:Lecture, October 4, 2018. 6:00 pm Metcalf Auditorium, RISD Museum/Chace Center. The division of Liberal Arts, THAD department and RISD Museum welcome author and Design historian Alison Clarke to RISD to give a lecture titled “Victor Papanek: Design, Ecology and Global Activism. In 1968, Papanek described the Design profession as a mode of “do-it-yourself murder” that generates waste, wreaks ecological havoc and excludes the most socially disadvantaged. Design, he warned, had become preoccupied with “the concocting of such inane trivia as mink-covered toilet-seats, electronic fingernail polish dryers and baroque fly-swatters,” rather than solving “real world” needs. Based on the forthcoming book Victor Papanek: Designer for the Real World (MIT Press) and research for a recent co-curated exhibition with the Vitra Design Museum, Germany, the lecture will explore how Papanek’s iconoclastic Designs, provocative journalism and unique global pedagogic initiatives upended the complacency of the 1960s and ’70s Design establishment. Clarke will examine how this shift in the perception of Design as a political tool was part of a broader challenge to commodity culture that drew on feminist and counter-culture ideas of non-capitalist production, African-American civil rights and global post-colonial activism, and a burgeoning ecological movement. She will conclude by examining the legacy of Papanek’s ideas in contemporary Design discourse. This event is sponsored by the Division of Liberal Arts graduate programs in Global Arts and Cultures and Nature-Culture-Sustainability Studies in conjunction with the RISD Museum’s Repair and Design Futures Exhibition and RISD Global. Alison J. Clarke is a Design historian and trained social anthropologist. She is chair of Design History and Theory and Director of the Victor J. Papanek Foundation, University of Applied Arts Vienna, and taught previously at the Royal College of Art, London. Professor Clarke’s publications include Tupperware: The Promise of Plastic in 1950s America, which became the basis of an Emmy Award nominated PBS documentary, Design Anthropology: Object Culture in the 21st Century (2017), and Émigré Cultures in Design and Architecture (with Elana Shapira, 2017). She is currently completing a monograph for MIT Press titled Victor Papanek: Designer for the Real World, as well as co-curating a related exhibition at the Vitra Design Museum, Germany.https://digitalcommons.risd.edu/liberalarts_ncss_eventposters/1002/thumbnail.jp
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Victor Papanek: Design, Ecology, and Global Activism | Alison Clarke: Minimal Design Team Flowchart
DigitalCommons@RISD, 2018Co-Authors: Division, Liberal Arts, Department, Theory History Of Art & & Design, Museum Risd, Global RisdAbstract:Lecture, October 4, 2018. 6:00 pm Metcalf Auditorium, RISD Museum/Chace Center. The division of Liberal Arts, THAD department and RISD Museum welcome author and Design historian Alison Clarke to RISD to give a lecture titled “Victor Papanek: Design, Ecology and Global Activism. In 1968, Papanek described the Design profession as a mode of “do-it-yourself murder” that generates waste, wreaks ecological havoc and excludes the most socially disadvantaged. Design, he warned, had become preoccupied with “the concocting of such inane trivia as mink-covered toilet-seats, electronic fingernail polish dryers and baroque fly-swatters,” rather than solving “real world” needs. Based on the forthcoming book Victor Papanek: Designer for the Real World (MIT Press) and research for a recent co-curated exhibition with the Vitra Design Museum, Germany, the lecture will explore how Papanek’s iconoclastic Designs, provocative journalism and unique global pedagogic initiatives upended the complacency of the 1960s and ’70s Design establishment. Clarke will examine how this shift in the perception of Design as a political tool was part of a broader challenge to commodity culture that drew on feminist and counter-culture ideas of non-capitalist production, African-American civil rights and global post-colonial activism, and a burgeoning ecological movement. She will conclude by examining the legacy of Papanek’s ideas in contemporary Design discourse. This event is sponsored by the Division of Liberal Arts graduate programs in Global Arts and Cultures and Nature-Culture-Sustainability Studies in conjunction with the RISD Museum’s Repair and Design Futures Exhibition and RISD Global. Alison J. Clarke is a Design historian and trained social anthropologist. She is chair of Design History and Theory and Director of the Victor J. Papanek Foundation, University of Applied Arts Vienna, and taught previously at the Royal College of Art, London. Professor Clarke’s publications include Tupperware: The Promise of Plastic in 1950s America, which became the basis of an Emmy Award nominated PBS documentary, Design Anthropology: Object Culture in the 21st Century (2017), and Émigré Cultures in Design and Architecture (with Elana Shapira, 2017). She is currently completing a monograph for MIT Press titled Victor Papanek: Designer for the Real World, as well as co-curating a related exhibition at the Vitra Design Museum, Germany.https://digitalcommons.risd.edu/liberalarts_ncss_eventposters/1001/thumbnail.jp
Zhaoyang Sun - One of the best experts on this subject based on the ideXlab platform.
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methodology of integrated knowledge management in lifecycle of product development process and its implementation
Lecture Notes in Computer Science, 2005Co-Authors: Peisi Zhong, Mei Liu, Dazhi Liu, Shuhui Ding, Zhaoyang SunAbstract:This paper first provides a literature review of product development and knowledge management including product development process, Design History and domain knowledge. It then presents a method for knowledge-based multi-view process modeling including process implementation, process monitoring, and knowledge management. The integrated framework and hierarchical model of the Design History is built. The relationship among process History, Design intent and domain knowledge is analyzed, and the method for representation and acquisition of process History, Design intent and domain knowledge is presented. The multi-agent based architecture of the knowledge-based product development process management (PDPM) system and its functional modules are described, and the architecture of integrated knowledge management (IKM) system based on PDPM is set up and developed with a B/C/S (Browser/Client/Server) structure. The system is used successfully during the lifecycle of a new type of railway rolling stock development.