Medical Device Cybersecurity for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers
Author: Axel Wirth
Publisher: Artech House
Total Pages: 270
Release: 2020-08-31
Genre: Computers
ISBN: 163081816X
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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 for Engineers and Manufacturers

Medical Device Cybersecurity for Engineers and Manufacturers
Author: Axel Wirth
Publisher:
Total Pages: 0
Release: 2020
Genre: Computer security
ISBN: 9781523145980
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" Cybersecurity for medical devices is no longer optional. We must not allow sensationalism or headlines to drive the discussiońŒ 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

Medical Device Cybersecurity
Author: Axel Wirth
Publisher: Artech House Publishers
Total Pages: 270
Release: 2020-08-31
Genre:
ISBN: 9781630818159
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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.

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition
Author:
Publisher:
Total Pages: 0
Release: 2024-10-31
Genre: Technology & Engineering
ISBN: 9781630819910
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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

Cybersecurity for Connected Medical Devices

Cybersecurity for Connected Medical Devices
Author: Arnab Ray
Publisher: Academic Press
Total Pages: 334
Release: 2021-11-09
Genre: Computers
ISBN: 0128182636
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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

Human resources for medical devices - the role of biomedical engineers

Human resources for medical devices - the role of biomedical engineers
Author: World Health Organization
Publisher: World Health Organization
Total Pages: 0
Release: 2017-05-09
Genre: Medical
ISBN: 9789241565479
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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.

Inspection of Medical Devices

Inspection of Medical Devices
Author: Almir Badnjević
Publisher: Springer Nature
Total Pages: 441
Release: 2023-12-28
Genre: Technology & Engineering
ISBN: 3031434447
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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!

Medical Device Design

Medical Device Design
Author:
Publisher: Academic Press
Total Pages: 369
Release: 2012-12-17
Genre: Technology & Engineering
ISBN: 0123919436
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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

Reliable Design of Medical Devices

Reliable Design of Medical Devices
Author: Richard C. Fries
Publisher: CRC Press
Total Pages: 490
Release: 2005-11-21
Genre: Medical
ISBN: 1420027948
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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.

Cybersecurity for Industry 4.0

Cybersecurity for Industry 4.0
Author: Lane Thames
Publisher: Springer
Total Pages: 273
Release: 2017-04-03
Genre: Computers
ISBN: 3319506609
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This book introduces readers to cybersecurity and its impact on the realization of the Industry 4.0 vision. It covers the technological foundations of cybersecurity within the scope of the Industry 4.0 landscape and details the existing cybersecurity threats faced by Industry 4.0, as well as state-of-the-art solutions with regard to both academic research and practical implementations. Industry 4.0 and its associated technologies, such as the Industrial Internet of Things and cloud-based design and manufacturing systems are examined, along with their disruptive innovations. Further, the book analyzes how these phenomena capitalize on the economies of scale provided by the Internet. The book offers a valuable resource for practicing engineers and decision makers in industry, as well as researchers in the design and manufacturing communities and all those interested in Industry 4.0 and cybersecurity.