Medical Devices

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Medical Device Cybersecurity for Engineers and Manufacturers

Author : Axel Wirth
Publisher : Artech House
ISBN 13 : 163081816X
Total Pages : 303 pages
Book Rating : 4.6/5 (38 download)

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Book Synopsis Medical Device Cybersecurity for Engineers and Manufacturers by : Axel Wirth

Download or read book Medical Device Cybersecurity for Engineers and Manufacturers written by Axel Wirth and published by Artech House. This book was released on 2020-08-31 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Materials and Coatings for Medical Devices

Author :
Publisher : ASM International
ISBN 13 : 1615031359
Total Pages : 453 pages
Book Rating : 4.6/5 (15 download)

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Book Synopsis Materials and Coatings for Medical Devices by :

Download or read book Materials and Coatings for Medical Devices written by and published by ASM International. This book was released on 2009-01-01 with total page 453 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Materials Information Society, MPMD-Materials and Processes for Medical Devices."

Plastics in Medical Devices

Author : Vinny R. Sastri
Publisher : Elsevier
ISBN 13 : 081552028X
Total Pages : 289 pages
Book Rating : 4.8/5 (155 download)

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Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri

Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Medical Devices

Author : Seeram Ramakrishna
Publisher : Woodhead Publishing
ISBN 13 : 0081002912
Total Pages : 253 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Medical Devices by : Seeram Ramakrishna

Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 253 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Medical Devices Law and Regulation Answer Book

Author : Suzan Onel
Publisher :
ISBN 13 : 9781402441622
Total Pages : 0 pages
Book Rating : 4.4/5 (416 download)

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Book Synopsis Medical Devices Law and Regulation Answer Book by : Suzan Onel

Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Implantable Electronic Medical Devices

Author : Dennis Fitzpatrick
Publisher : Elsevier
ISBN 13 : 012416577X
Total Pages : 194 pages
Book Rating : 4.1/5 (241 download)

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Book Synopsis Implantable Electronic Medical Devices by : Dennis Fitzpatrick

Download or read book Implantable Electronic Medical Devices written by Dennis Fitzpatrick and published by Elsevier. This book was released on 2014-11-05 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Handbook of Human Factors in Medical Device Design

Author : Matthew Bret Weinger
Publisher : CRC Press
ISBN 13 : 1420063510
Total Pages : 822 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Handbook of Human Factors in Medical Device Design by : Matthew Bret Weinger

Download or read book Handbook of Human Factors in Medical Device Design written by Matthew Bret Weinger and published by CRC Press. This book was released on 2010-12-13 with total page 822 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

The Danger Within Us

Author : Jeanne Lenzer
Publisher : Little, Brown
ISBN 13 : 0316343781
Total Pages : 306 pages
Book Rating : 4.3/5 (163 download)

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Book Synopsis The Danger Within Us by : Jeanne Lenzer

Download or read book The Danger Within Us written by Jeanne Lenzer and published by Little, Brown. This book was released on 2017-12-12 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Did you know... Medical interventions have become the third leading cause of death in America. An estimated 10 percent of Americans are implanted with medical devices -- like pacemakers, artificial hips, cardiac stents, etc. The overwhelming majority of high-risk implanted devices have never undergone a single clinical trial. In The Danger Within Us, award-winning journalist Jeanne Lenzer brings these horrifying statistics to life through the story of one working class man who, after his "cure" nearly kills him, ends up in a battle for justice against the medical establishment. His crusade leads Lenzer on a journey through the dark underbelly of the medical device industry, a fascinating and disturbing world that hasn't been written about before. What Lenzer exposes will shock readers: rampant corruption, elaborate cover-ups, shameless profiteering, and astonishing lack of oversight, all of which leads to dangerous devices (from artificial hips to pacemakers) going to market and into our bodies. In the vein of America's Bitter Pill and A Civil Action, The Danger Within Us is a stirring call for reform and a must-read for anyone who cares about the future of American healthcare. "Before you get anything implanted in your body, read this book."-Shannon Brownlee, author of Overtreated

Innovation and Protection

Author : I. Glenn Cohen
Publisher : Cambridge University Press
ISBN 13 : 1108838634
Total Pages : 295 pages
Book Rating : 4.1/5 (88 download)

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Book Synopsis Innovation and Protection by : I. Glenn Cohen

Download or read book Innovation and Protection written by I. Glenn Cohen and published by Cambridge University Press. This book was released on 2022-04-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

Cybersecurity for Connected Medical Devices

Author : Arnab Ray
Publisher : Academic Press
ISBN 13 : 0128182636
Total Pages : 334 pages
Book Rating : 4.1/5 (281 download)

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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

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Usability Testing of Medical Devices

Author : Michael E. Wiklund, P.E.
Publisher : CRC Press
ISBN 13 : 1466595892
Total Pages : 472 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Usability Testing of Medical Devices by : Michael E. Wiklund, P.E.

Download or read book Usability Testing of Medical Devices written by Michael E. Wiklund, P.E. and published by CRC Press. This book was released on 2015-12-23 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h

Medical Regulatory Affairs

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Medical Regulatory Affairs by : Jack Wong

Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Biofilms and Implantable Medical Devices

Author : Ying Deng
Publisher : Woodhead Publishing
ISBN 13 : 0081003986
Total Pages : 240 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Biofilms and Implantable Medical Devices by : Ying Deng

Download or read book Biofilms and Implantable Medical Devices written by Ying Deng and published by Woodhead Publishing. This book was released on 2016-10-24 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biofilms and Implantable Medical Devices: Infection and Control explores the increasing use of permanent and semi-permanent implants and indwelling medical devices. As an understanding of the growth and impact of biofilm formation on these medical devices and biomaterials is vital for protecting the health of the human host, this book provides readers with a comprehensive treatise on biofilms and their relationship with medical devices, also reporting on infections and associated strategies for prevention. - Provides useful information on the fundamentals of biofilm problems in medical devices - Discusses biofilm problems in a range of medical devices - Focuses on strategies for prevention of biofilm formation

Human resources for medical devices - the role of biomedical engineers

Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9789241565479
Total Pages : 0 pages
Book Rating : 4.5/5 (654 download)

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Book Synopsis Human resources for medical devices - the role of biomedical engineers by : World Health Organization

Download or read book Human resources for medical devices - the role of biomedical engineers written by World Health Organization and published by World Health Organization. This book was released on 2017-05-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Medical Devices and the Public's Health

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212421
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine

Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-11-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

The Design and Manufacture of Medical Devices

Author : J. Paulo Davim
Publisher : Elsevier
ISBN 13 : 1908818182
Total Pages : 382 pages
Book Rating : 4.9/5 (88 download)

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Book Synopsis The Design and Manufacture of Medical Devices by : J. Paulo Davim

Download or read book The Design and Manufacture of Medical Devices written by J. Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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