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Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical d
Book Synopsis Medical Devices and Systems by : Joseph D. Bronzino
Download or read book Medical Devices and Systems written by Joseph D. Bronzino and published by CRC Press. This book was released on 2006-04-19 with total page 1404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last century, medicine has come out of the "black bag" and emerged as one of the most dynamic and advanced fields of development in science and technology. Today, biomedical engineering plays a critical role in patient diagnosis, care, and rehabilitation. More than ever, biomedical engineers face the challenge of making sure that medical d
Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
Book Synopsis Medical Device Technologies by : Gail D. Baura
Download or read book Medical Device Technologies written by Gail D. Baura and published by Academic Press. This book was released on 2011-10-07 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
Book Synopsis Cybersecurity for Connected Medical Devices by : Arnab Ray
Download or read book Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 2021-11-09 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King
Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
Book Synopsis Medical Device Technologies by : Gail Baura
Download or read book Medical Device Technologies written by Gail Baura and published by Academic Press. This book was released on 2011-09-28 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts
Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more. After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.
Book Synopsis Medical Devices by : Martin Culjat
Download or read book Medical Devices written by Martin Culjat and published by John Wiley & Sons. This book was released on 2012-11-07 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing the exploding interest in bioengineering for healthcare applications, this book provides readers with detailed yet easy-to-understand guidance on biomedical device engineering. Written by prominent physicians and engineers, Medical Devices: Surgical and Image-Guided Technologies is organized into stand-alone chapters covering devices and systems in diagnostic, surgical, and implant procedures. Assuming only basic background in math and science, the authors clearly explain the fundamentals for different systems along with such topics as engineering considerations, therapeutic techniques and applications, future trends, and more. After describing how to manage a design project for medical devices, the book examines the following: Instruments for laparoscopic and ophthalmic surgery, plus surgical robotics Catheters in vascular therapy and energy-based hemostatic surgical devices Tissue ablation systems and the varied uses of lasers in medicine Vascular and cardiovascular devices, plus circulatory support devices Ultrasound transducers, X-ray imaging, and neuronavigation An absolute must for biomedical engineers, Medical Devices: Surgical and Image-Guided Technologies is also an invaluable guide for students in all engineering majors and pre-med programs interested in exploring this fascinating field.
This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.
Book Synopsis Stretchable Bioelectronics for Medical Devices and Systems by : John A. Rogers
Download or read book Stretchable Bioelectronics for Medical Devices and Systems written by John A. Rogers and published by Springer. This book was released on 2016-03-31 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.
Book Synopsis Medical Device Quality Management Systems by : Susanne Manz
Download or read book Medical Device Quality Management Systems written by Susanne Manz and published by Academic Press. This book was released on 2018-10-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry.
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
Book Synopsis Medical Device Software Verification, Validation and Compliance by : David A. Vogel
Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."
