Medical Device Cybersecurity For Engineers And Manufacturers Second Edition

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Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition

Author :
Publisher :
ISBN 13 : 9781630819910
Total Pages : 0 pages
Book Rating : 4.8/5 (199 download)

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Book Synopsis Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition by :

Download or read book Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition written by and published by . This book was released on 2024-10-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Why Secure Medical Devices?, Establishing Cybersecurity Focus Within the MD, Global Regulations and Standards, Use Environments, Supply Chain Management, Secure Development and Production for Medical Device Manufacturers, Documentation and Artifacts, Postmarket Vulnerability Management, Incident Response & Communications, Device Security Lifecycle for Healthcare Delivery Organizations, Aspects of IT Security in Medical Device Systems, Applying Cryptography to Medical Device Systems, Cybersecurity Failures, Common Myths & Excuses

Medical Device Cybersecurity for Engineers and Manufacturers

Author : Axel Wirth
Publisher : Artech House
ISBN 13 : 163081816X
Total Pages : 270 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 270 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.

Medical Device Cybersecurity

Author : Axel Wirth
Publisher : Artech House Publishers
ISBN 13 : 9781630818159
Total Pages : 270 pages
Book Rating : 4.8/5 (181 download)

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Book Synopsis Medical Device Cybersecurity by : Axel Wirth

Download or read book Medical Device Cybersecurity written by Axel Wirth and published by Artech House Publishers. This book was released on 2020-08-31 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book provides a complete guide for medical device manufacturers seeking to implement lifecycle processes that secure their premarket and postmarket activities. This step-by-step book educates manufacturers about the implementation of security best practices in accord with industry standards and expectations, advising the reader about everything from high-level concepts to real-world solutions and tools. It walks the reader through the security aspects of every lifecycle phase of the product, including concept; design; implementation; supply chain; manufacturing; postmarket; maintenance; and end of life. It details the practices, processes, and outputs necessary to create a secure medical device capable of gaining regulatory approval and meeting market entry requirements.This book equips medical device manufacturers with the knowledge and capability required to produce secure products that anticipate healthcare delivery organizations' (HDOs) and patients' needs and expectations, meet market-entry requirements set by regulators and standards organizations, and reduce patient, HDO, and manufacturer exposure to increasingly sophisticated cyber adversaries.It explores the differences between cybersecurity in an IT/MIS environment versus the application and management of cybersecurity during the development of an embedded product, as typically found in the medical device ecosystem. Designers and manufacturers learn how to mitigate or avoid common cybersecurity vulnerabilities frequently introduced during development and production. It details regulatory and customer expectations for documentation artifacts and deliverables that demonstrate cybersecurity compliance and features as well as regulator expectations for postmarket activities during device service life. Readers become aware of the growing sophistication of cyber adversaries disproportionate to industry understanding of cybersecurity exposure and potential impacts.

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

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Medical Device Design

Author :
Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 369 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by :

Download or read book Medical Device Design written by and published by Academic Press. This book was released on 2012-12-17 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

Design of Biomedical Devices and Systems Second edition

Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 1439878072
Total Pages : 424 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Design of Biomedical Devices and Systems Second edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This

The Medical Device R&D Handbook, Second Edition

Author : Theodore R. Kucklick
Publisher : CRC Press
ISBN 13 : 143981189X
Total Pages : 513 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis The Medical Device R&D Handbook, Second Edition by : Theodore R. Kucklick

Download or read book The Medical Device R&D Handbook, Second Edition written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.

The Medical Device R&D Handbook

Author : Theodore R. Kucklick
Publisher : CRC Press
ISBN 13 : 1420038354
Total Pages : 376 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis The Medical Device R&D Handbook by : Theodore R. Kucklick

Download or read book The Medical Device R&D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2005-11-21 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

Reliable Design of Medical Devices, Third Edition

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1439894914
Total Pages : 505 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Reliable Design of Medical Devices, Third Edition by : Richard C. Fries

Download or read book Reliable Design of Medical Devices, Third Edition written by Richard C. Fries and published by CRC Press. This book was released on 2012-09-06 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Cybersecurity for Hospitals and Healthcare Facilities

Author : Luis Ayala
Publisher : Apress
ISBN 13 : 1484221559
Total Pages : 147 pages
Book Rating : 4.4/5 (842 download)

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Book Synopsis Cybersecurity for Hospitals and Healthcare Facilities by : Luis Ayala

Download or read book Cybersecurity for Hospitals and Healthcare Facilities written by Luis Ayala and published by Apress. This book was released on 2016-09-06 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Learn how to detect and prevent the hacking of medical equipment at hospitals and healthcare facilities. A cyber-physical attack on building equipment pales in comparison to the damage a determined hacker can do if he/she gains access to a medical-grade network as a medical-grade network controls the diagnostic, treatment, and life support equipment on which lives depend. News reports inform us how hackers strike hospitals with ransomware that prevents staff from accessing patient records or scheduling appointments. Unfortunately, medical equipment also can be hacked and shut down remotely as a form of extortion. Criminal hackers will not ask for a $500 payment to unlock an MRI, PET or CT scan, or X-ray machine—they will ask for much more. Litigation is bound to follow and the resulting punitive awards will drive up hospital insurance costs and healthcare costs in general. This will undoubtedly result in increased regulations for hospitals and higher costs for compliance. Unless hospitals and other healthcare facilities take the steps necessary to secure their medical-grade networks, they will be targeted for cyber-physical attack, possibly with life-threatening consequences. Cybersecurity for Hospitals and Healthcare Facilities is a wake-up call explaining what hackers can do, why hackers would target a hospital, the way hackers research a target, ways hackers can gain access to a medical-grade network (cyber-attack vectors), and ways hackers hope to monetize their cyber-attack. By understanding and detecting the threats, you can take action now—before your hospital becomes the next victim. What You Will Learn: Determine how vulnerable hospital and healthcare building equipment is to cyber-physical attack Identify possible ways hackers can hack hospital and healthcare facility equipment Recognize the cyber-attack vectors—or paths by which a hacker or cracker can gain access to a computer, a medical-grade network server, or expensive medical equipment in order to deliver a payload or malicious outcome Detect and prevent man-in-the-middle or denial-of-service cyber-attacks Find and prevent hacking of the hospital database and hospital web application Who This Book Is For: Hospital administrators, healthcare professionals, hospital & healthcare facility engineers and building managers, hospital & healthcare facility IT professionals, and HIPAA professionals

Validation for Medical Device and Diagnostic Manufacturers, Second Edition

Author : Carol V. Desain
Publisher : CRC Press
ISBN 13 : 9781574910636
Total Pages : 332 pages
Book Rating : 4.9/5 (16 download)

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Book Synopsis Validation for Medical Device and Diagnostic Manufacturers, Second Edition by : Carol V. Desain

Download or read book Validation for Medical Device and Diagnostic Manufacturers, Second Edition written by Carol V. Desain and published by CRC Press. This book was released on 1997-09-30 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.

Security and Privacy for Implantable Medical Devices

Author : Wayne Burleson
Publisher : Springer Science & Business Media
ISBN 13 : 1461416744
Total Pages : 204 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Security and Privacy for Implantable Medical Devices by : Wayne Burleson

Download or read book Security and Privacy for Implantable Medical Devices written by Wayne Burleson and published by Springer Science & Business Media. This book was released on 2013-12-03 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD). It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from Computer Security and Cryptography present new research which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in Computer Science privacy research, as well as lightweight solutions appropriate for implementation in IMDs.

Handbook of Medical Device Regulatory Affairs in Asia

Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 0429996772
Total Pages : 620 pages
Book Rating : 4.4/5 (299 download)

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Book Synopsis Handbook of Medical Device Regulatory Affairs in Asia by : Jack Wong

Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Inspection of Medical Devices

Author : Almir Badnjević
Publisher : Springer Nature
ISBN 13 : 3031434447
Total Pages : 441 pages
Book Rating : 4.0/5 (314 download)

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Book Synopsis Inspection of Medical Devices by : Almir Badnjević

Download or read book Inspection of Medical Devices written by Almir Badnjević and published by Springer Nature. This book was released on 2023-12-28 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!

The Medical Device R&D Handbook

Author : Theodore R. Kucklick
Publisher : CRC Press
ISBN 13 : 104007913X
Total Pages : 513 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis The Medical Device R&D Handbook by : Theodore R. Kucklick

Download or read book The Medical Device R&D Handbook written by Theodore R. Kucklick and published by CRC Press. This book was released on 2012-12-05 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designer

Medical Device Technologies

Author : Gail D. Baura
Publisher : Academic Press
ISBN 13 : 012374976X
Total Pages : 529 pages
Book Rating : 4.1/5 (237 download)

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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