Medical Devices And Systems
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| Author | : Joseph D. Bronzino |
| Publisher | : CRC Press |
| Total Pages | : 1404 |
| Release | : 2006-04-19 |
| Genre | : Medical |
| ISBN | : 1420003860 |
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 |
| Total Pages | : 529 |
| Release | : 2011-10-07 |
| Genre | : Medical |
| ISBN | : 012374976X |
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 | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 508 |
| Release | : 2018-10-03 |
| Genre | : Medical |
| ISBN | : 0429786069 |
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 | : Martin Culjat |
| Publisher | : John Wiley & Sons |
| Total Pages | : 452 |
| Release | : 2012-11-07 |
| Genre | : Science |
| ISBN | : 1118453530 |
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.
| Author | : World Health Organization |
| Publisher | : World Health Organization |
| Total Pages | : 0 |
| Release | : 2017-05-09 |
| Genre | : Medical |
| ISBN | : 9789241565479 |
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 | : Carl T. DeMarco |
| Publisher | : Quality Press |
| Total Pages | : 369 |
| Release | : 2011-01-01 |
| Genre | : Business & Economics |
| ISBN | : 0873898168 |
| Author | : Arnab Ray |
| Publisher | : Academic Press |
| Total Pages | : 334 |
| Release | : 2021-11-09 |
| Genre | : Computers |
| ISBN | : 0128182636 |
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
| Author | : Seeram Ramakrishna |
| Publisher | : Woodhead Publishing |
| Total Pages | : 253 |
| Release | : 2015-08-18 |
| Genre | : Medical |
| ISBN | : 0081002912 |
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
| Author | : Amiram Daniel |
| Publisher | : Quality Press |
| Total Pages | : 338 |
| Release | : 2008-01-01 |
| Genre | : Medical |
| ISBN | : 0873897404 |
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 | : Axel Wirth |
| Publisher | : Artech House |
| Total Pages | : 270 |
| Release | : 2020-08-31 |
| Genre | : Computers |
| ISBN | : 163081816X |
Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussion… Nevertheless, we must proceed with urgency. In the end, this is about preventing patient harm and preserving patient trust. A comprehensive guide to medical device secure lifecycle management, this is a book for engineers, managers, and regulatory specialists. Readers gain insight into the security aspects of every phase of the product lifecycle, including concept, design, implementation, supply chain, manufacturing, postmarket surveillance, maintenance, updates, and end of life. Learn how to mitigate or completely avoid common cybersecurity vulnerabilities introduced during development and production. Grow your awareness of cybersecurity development topics ranging from high-level concepts to practical solutions and tools. Get insight into emerging regulatory and customer expectations. Uncover how to minimize schedule impacts and accelerate time-to-market while still accomplishing the main goal: reducing patient and business exposure to cybersecurity risks. Medical Device Cybersecurity for Engineers and Manufacturers is designed to help all stakeholders lead the charge to a better medical device security posture and improve the resilience of our medical device ecosystem.
