Medical Device Cybersecurity For Engineers And Manufacturers
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Medical Device Cybersecurity For Engineers And Manufacturers
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Author : Axel Wirth
language : en
Publisher: Artech House
Release Date : 2020-08-31
Medical Device Cybersecurity For Engineers And Manufacturers written by Axel Wirth and has been published by Artech House this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-31 with Computers categories.
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 Second Edition
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Author : Axel Wirth
language : en
Publisher: Artech House
Release Date : 2024-10-31
Medical Device Cybersecurity For Engineers And Manufacturers Second Edition written by Axel Wirth and has been published by Artech House this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-10-31 with Computers categories.
Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition removes the mystery from cybersecurity engineering and regulatory processes and practices, showing medical device manufacturers how to produce and maintain devices that meet evolving regulatory expectations and reduce cybersecurity risks to business and patients. It represents a complete guide for medical device manufacturers seeking to implement lifecycle processes that secure their premarket and postmarket activities. This step-by-step guide educates manufacturers about the implementation of security best practices in accordance with industry standards and expectations, advising the reader about everything from high-level concepts to real-world solutions and tools. It focuses on 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. Reflecting rapid industry developments, regulatory changes, and technology advances, this new edition equips manufacturers with the knowledge to produce secure products that meet regulatory and market requirements while anticipating threats from sophisticated cyber adversaries. It's an indispensable resource for a wide range of professionals involved in medical device manufacturing, including engineering management, software/firmware engineers, business managers, regulatory professionals, contract manufacturers, FDA regulators, product/project managers, sales and marketing teams, and healthcare delivery organizations.
Cybersecurity For Connected Medical Devices
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Author : Arnab Ray
language : en
Publisher: Elsevier
Release Date : 2021-11-10
Cybersecurity For Connected Medical Devices written by Arnab Ray and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-10 with Computers categories.
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
Medical Device Cybersecurity
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Author : Axel Wirth
language : en
Publisher: Artech House Publishers
Release Date : 2020-08-31
Medical Device Cybersecurity written by Axel Wirth and has been published by Artech House Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-08-31 with categories.
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
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Author : Arnab Ray
language : en
Publisher: Academic Press
Release Date : 2021-11-09
Cybersecurity For Connected Medical Devices written by Arnab Ray and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-09 with Computers categories.
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
Diabetes Digital Health And Telehealth
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Author : David C. Klonoff
language : en
Publisher: Academic Press
Release Date : 2022-08-05
Diabetes Digital Health And Telehealth written by David C. Klonoff and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-05 with Medical categories.
Diabetes Digital Health and Telehealth explains, from technologic, economic and sociologic standpoints how digital health and telehealth have come to dominate the management of diabetes. The book also includes information on improved telemedicine tools and platforms for communicating with patients, reviewing medical records, and interpreting data from wearable devices. In addition, evolving wearable sensors such as continuous glucose monitors, closed loop automated insulin delivery systems, cuffless blood pressure monitors, exercise monitors and smart insulin pens are covered. - Covers advances in the fields of digital health and telehealth, including research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes - Discusses improved telemedicine tools and platforms for communicating with patients, reviewing medical records and interpreting data from wearable devices - Analyzes information gaps, research methods, relevant types of evidence, and viable endpoints for assessing the clinical and economic benefits of digital health and telehealth for diabetes
Medical Device Technologies
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Author : Gail Baura
language : en
Publisher: Academic Press
Release Date : 2011-09-28
Medical Device Technologies written by Gail Baura and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-28 with Technology & Engineering categories.
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
Introduction To Medical Software
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Author : Xenophon Papademetris
language : en
Publisher: Cambridge University Press
Release Date : 2022-05-05
Introduction To Medical Software written by Xenophon Papademetris and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-05-05 with Business & Economics categories.
A concise and accessible overview of the design, implementation and management of medical software.
Careers In Biomedical Engineering
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Author : Michael Levin-Epstein
language : en
Publisher: Academic Press
Release Date : 2019-01-31
Careers In Biomedical Engineering written by Michael Levin-Epstein and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-31 with Computers categories.
Careers in Biomedical Engineering offers readers a comprehensive overview of new career opportunities in the field of biomedical engineering. The book begins with a discussion of the extensive changes which the biomedical engineering profession has undergone in the last 10 years. Subsequent sections explore educational, training and certification options for a range of subspecialty areas and diverse workplace settings. As research organizations are looking to biomedical engineers to provide project-based assistance on new medical devices and/or help on how to comply with FDA guidelines and best practices, this book will be useful for undergraduate and graduate biomedical students, practitioners, academic institutions, and placement services.
28 Days To Save The World
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Author : Dan Purvis
language : en
Publisher: BenBella Books
Release Date : 2022-12-06
28 Days To Save The World written by Dan Purvis and has been published by BenBella Books this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-12-06 with Business & Economics categories.
In 2020, engineering firm Velentium faced an unprecedented ask: partner with a small medical device company and a very large vehicle manufacturer to increase emergency ventilator production from hundreds per month to thousands per week—in just 28 days. Serving on the frontlines of pandemic response is enough pressure to cause any size business to buckle, but the small firm thrived and even doubled in size to complete their manufacturing scale-up known as Project V: seven months of work in six weeks. Velentium’s cofounder Dan Purvis attributes their extraordinary success to their decade-in-the-making company culture, which buoyed them in the face of an unforeseeable crisis. In 28 Days to Save the World, he lays out how to harness the power of organizational culture to prepare your small business to weather any challenges ahead. Every quarter, more than 30 million small-business entrepreneurs face innumerable familiar crises—of management, strategic direction, cashflow and credit, staff, and customers—that can spell their doom. Drawing from his twenty-five years of experience as a small-business leader, and with gripping stories from Project V, Purvis reveals crisis-tested methods for turning challenges into opportunities. He shows how a well-crafted culture: Reveals the right path in a crisis Taps into team members’ inner motivation Unites leaders and followers Compels action in “made for you” moments Enables you to step up to global challenges Catalyzes deep connections between people inside and outside your organization When a defining moment arrives for your organization, will your team be ready? 28 Days to Save the World is an essential resource for ensuring that you are.