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English | 2021 | ISBN: 0128182628 | 334 pages | True pdf, epub | 22.83 MB
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 Devicescovers 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 capabilitiesDiscusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management SystemProvides a candidate method for system and software threat modellingProvides an overview of cybersecurity risk management for medical devicesPresents technical cybersecurity controls for secure design of medical devicesProvides an overview of cybersecurity verification and validation for medical devicesPresents an approach to logically structure cybersecurity regulatory submissions
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