Mastering Safety Risk Management for Medical and In Vitro Devices

Mastering Safety Risk Management for Medical and In Vitro Devices

Author: Jayet Moon

Publisher: ASQ Quality Press

Published: 2024-05-10

Total Pages: 0

ISBN-13: 9781636941707

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When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).


Book Synopsis Mastering Safety Risk Management for Medical and In Vitro Devices by : Jayet Moon

Download or read book Mastering Safety Risk Management for Medical and In Vitro Devices written by Jayet Moon and published by ASQ Quality Press. This book was released on 2024-05-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product's life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

Mastering Safety Risk Management for Medical and In Vitro Devices

Mastering Safety Risk Management for Medical and In Vitro Devices

Author: Jayet Moon

Publisher: Quality Press

Published: 2024-05-10

Total Pages: 305

ISBN-13: 1636941710

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When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).


Book Synopsis Mastering Safety Risk Management for Medical and In Vitro Devices by : Jayet Moon

Download or read book Mastering Safety Risk Management for Medical and In Vitro Devices written by Jayet Moon and published by Quality Press. This book was released on 2024-05-10 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).

Safety Risk Management for Medical Devices

Safety Risk Management for Medical Devices

Author: Bijan Elahi

Publisher: Academic Press

Published: 2021-11-11

Total Pages: 541

ISBN-13: 0323918239

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Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation


Book Synopsis Safety Risk Management for Medical Devices by : Bijan Elahi

Download or read book Safety Risk Management for Medical Devices written by Bijan Elahi and published by Academic Press. This book was released on 2021-11-11 with total page 541 pages. Available in PDF, EPUB and Kindle. Book excerpt: Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Quality Risk Management in the FDA-regulated Industry

Quality Risk Management in the FDA-regulated Industry

Author: José Rodríguez Pérez

Publisher:

Published: 2017

Total Pages: 338

ISBN-13: 9780873899482

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Book Synopsis Quality Risk Management in the FDA-regulated Industry by : José Rodríguez Pérez

Download or read book Quality Risk Management in the FDA-regulated Industry written by José Rodríguez Pérez and published by . This book was released on 2017 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Devices and In Vitro Diagnostics

Medical Devices and In Vitro Diagnostics

Author: Christian Baumgartner

Publisher: Springer Nature

Published: 2023-08-26

Total Pages: 671

ISBN-13: 3031220919

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This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.


Book Synopsis Medical Devices and In Vitro Diagnostics by : Christian Baumgartner

Download or read book Medical Devices and In Vitro Diagnostics written by Christian Baumgartner and published by Springer Nature. This book was released on 2023-08-26 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-04-03

Total Pages: 442

ISBN-13: 0309158060

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.


Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine

Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Medical Device Regulations

Medical Device Regulations

Author: Michael Cheng

Publisher: World Health Organization

Published: 2003-09-16

Total Pages: 54

ISBN-13: 9241546182

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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.


Book Synopsis Medical Device Regulations by : Michael Cheng

Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Vessel Health and Preservation: The Right Approach for Vascular Access

Vessel Health and Preservation: The Right Approach for Vascular Access

Author: Nancy L. Moureau

Publisher: Springer

Published: 2019-06-10

Total Pages: 303

ISBN-13: 3030031497

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This Open access book offers updated and revised information on vessel health and preservation (VHP), a model concept first published in poster form in 2008 and in JVA in 2012, which has received a great deal of attention, especially in the US, UK and Australia. The book presents a model and a new way of thinking applied to vascular access and administration of intravenous treatment, and shows how establishing and maintaining a route of access to the bloodstream is essential for patients in acute care today. Until now, little thought has been given to an intentional process to guide selection, insertion and management of vascular access devices (VADs) and by default actions are based on crisis management when a quickly selected VAD fails. The book details how VHP establishes a framework or pathway model for each step of the patient experience, intentionally guiding, improving and eliminating risk when possible. The evidence points to the fact that reducing fragmentation, establishing a pathway, and teaching the process to all stakeholders reduces complications with intravenous therapy, improves efficiency and diminishes cost. As such this book appeals to bedside nurses, physicians and other health professionals.


Book Synopsis Vessel Health and Preservation: The Right Approach for Vascular Access by : Nancy L. Moureau

Download or read book Vessel Health and Preservation: The Right Approach for Vascular Access written by Nancy L. Moureau and published by Springer. This book was released on 2019-06-10 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Open access book offers updated and revised information on vessel health and preservation (VHP), a model concept first published in poster form in 2008 and in JVA in 2012, which has received a great deal of attention, especially in the US, UK and Australia. The book presents a model and a new way of thinking applied to vascular access and administration of intravenous treatment, and shows how establishing and maintaining a route of access to the bloodstream is essential for patients in acute care today. Until now, little thought has been given to an intentional process to guide selection, insertion and management of vascular access devices (VADs) and by default actions are based on crisis management when a quickly selected VAD fails. The book details how VHP establishes a framework or pathway model for each step of the patient experience, intentionally guiding, improving and eliminating risk when possible. The evidence points to the fact that reducing fragmentation, establishing a pathway, and teaching the process to all stakeholders reduces complications with intravenous therapy, improves efficiency and diminishes cost. As such this book appeals to bedside nurses, physicians and other health professionals.

China's Healthcare System and Reform

China's Healthcare System and Reform

Author: Lawton Robert Burns

Publisher: Cambridge University Press

Published: 2017-01-26

Total Pages: 929

ISBN-13: 1316738396

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This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.


Book Synopsis China's Healthcare System and Reform by : Lawton Robert Burns

Download or read book China's Healthcare System and Reform written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2017-01-26 with total page 929 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.

The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition

The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition

Author: Russell T. Westcott

Publisher: Quality Press

Published: 2013-10-07

Total Pages: 513

ISBN-13: 0873898613

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This handbook is a comprehensive reference source designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with the technological and societal concerns of the new millennium. The content of this fourth edition has been revised to reflect a more current global perspective and to match the updated Body of Knowledge (BoK) of ASQ’s Certified Manager of Quality/Organizational Excellence (CMQ/OE). In order to provide a broad perspective of quality management, this book has specifically been written to address: • Historical perspectives relating to the evolution of particular aspects of quality management, including recognized experts and their contributions • Key principles, concepts, and terminology relevant in providing quality leadership, and communicating quality needs and results • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, including common problems that the quality manager might experience when designing and implementing quality management, and insights as to why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination. Organized to follow the BoK exactly, throughout each section of this handbook the categorical BoK requirements associated with good quality management practices for that section are shown in a box preceding the pertinent text. These BoK requirements represent the range of content and the cognitive level to which multiple-choice questions can be presented. Although this handbook thoroughly prepares individuals for the ASQ CMQ/OE exam, the real value resides in post-exam usage as a day-to-day reference source for assessing quality applications and methodologies in daily processes. The content is written from the perspective of practitioners, and its relevance extends beyond traditional product quality applications.


Book Synopsis The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition by : Russell T. Westcott

Download or read book The Certified Manager of Quality/Organizational Excellence Handbook, Fourth Edition written by Russell T. Westcott and published by Quality Press. This book was released on 2013-10-07 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook is a comprehensive reference source designed to help professionals address organizational issues from the application of the basic principles of management to the development of strategies needed to deal with the technological and societal concerns of the new millennium. The content of this fourth edition has been revised to reflect a more current global perspective and to match the updated Body of Knowledge (BoK) of ASQ’s Certified Manager of Quality/Organizational Excellence (CMQ/OE). In order to provide a broad perspective of quality management, this book has specifically been written to address: • Historical perspectives relating to the evolution of particular aspects of quality management, including recognized experts and their contributions • Key principles, concepts, and terminology relevant in providing quality leadership, and communicating quality needs and results • Benefits associated with the application of key concepts and quality management principles • Best practices describing recognized approaches for good quality management • Barriers to success, including common problems that the quality manager might experience when designing and implementing quality management, and insights as to why some quality initiatives fail • Guidance for preparation to take the CMQ/OE examination. Organized to follow the BoK exactly, throughout each section of this handbook the categorical BoK requirements associated with good quality management practices for that section are shown in a box preceding the pertinent text. These BoK requirements represent the range of content and the cognitive level to which multiple-choice questions can be presented. Although this handbook thoroughly prepares individuals for the ASQ CMQ/OE exam, the real value resides in post-exam usage as a day-to-day reference source for assessing quality applications and methodologies in daily processes. The content is written from the perspective of practitioners, and its relevance extends beyond traditional product quality applications.