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Author: Joseph D. Bronzino
Publisher: CRC Press
ISBN: 1420003860
Category : Medical
Languages : en
Pages : 1404
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Book Description
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
Author: Joseph D. Bronzino
Publisher: CRC Press
ISBN: 1420003860
Category : Medical
Languages : en
Pages : 1404
Get Book Here
Book Description
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
Author: Gail D. Baura
Publisher: Academic Press
ISBN: 012374976X
Category : Medical
Languages : en
Pages : 529
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Book Description
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
Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 338
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Book Description
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.
Author: Dennis Fitzpatrick
Publisher: Elsevier
ISBN: 012416577X
Category : Technology & Engineering
Languages : en
Pages : 194
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Book Description
Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation therapy devices, and much more. Implantable Electronic Medical Devices equips the reader with essential background knowledge on the application of existing medical devices as well as providing an introduction to the latest techniques being used. - A catalogue of existing implantable electronic medical devices - Up-to-date information on the design of implantable electronic medical devices - Background information and reviews on the application and design of up-to-date implantable electronic medical devices
Author: Susanne Manz
Publisher: Academic Press
ISBN: 9780128142219
Category : Science
Languages : en
Pages : 0
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Book Description
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.
Author: Paul H. King
Publisher: CRC Press
ISBN: 0429786069
Category : Technology & Engineering
Languages : en
Pages : 543
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Book Description
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
Author: J. Paulo Davim
Publisher: Elsevier
ISBN: 1908818182
Category : Technology & Engineering
Languages : en
Pages : 382
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Book Description
Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. - Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device - Offers a practical approach to recent developments in the design and manufacture of medical devices - Presents a topic that is the focus of research in many important universities and centres of research worldwide
Author: Orlando Lopez
Publisher: Taylor & Francis
ISBN: 1351704346
Category : Business & Economics
Languages : en
Pages : 232
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Book Description
Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9789241565479
Category : Medical
Languages : en
Pages : 0
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Book Description
This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
ISBN: 0081002912
Category : Medical
Languages : en
Pages : 253
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Book Description
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process
