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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
Systems, software, and biomedical engineers working at medical device manufacturers and managers/leaders at medical device manufacturers, systems engineers and clinical/biomedical engineers working in clinical settings with medical devices
1. Introduction to Medical Device Cybersecurity
2. Basic cybersecurity concepts
3. Regulatory Overview
4. The Product Cybersecurity Organization
5. Cybersecurity Risk Management-I
6. Cybersecurity Risk Management-II
7. Cybersecurity Design Engineering
8. Supply Chain Cybersecurity Risk Management, Secure Product Development, Secure Manufacture, Vulnerability Management, and Cybersecurity Training
9. Product Security Governance and Regulatory Compliance
- No. of pages:
- © Academic Press 2021
- 15th November 2021
- Academic Press
- Paperback ISBN:
Arnab Ray has more than fifteen years of experience in cybersecurity and the engineering of high-confidence software systems. He has led product cybersecurity teams at multiple medical device manufacturers and has been responsible for the security architecture of several medical devices. Arnab Ray has a Ph.D. in Computer Science from Stony Brook University.
Professional cybersecurity engineer, medical device manufacturing industry, California, USA
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