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.
Foreword
Why Secure Medical Devices?
Establishing a Cybersecurity Focus
Supply Chain Management
Medical Device Manufacturers’ Development Cycle
Security in Production and Sales for Medical Device Manufacturers
Medical Device Manufacturer Postmarket Lifecycle
HDO Lifecycle
Documentation and Artifacts
Organizational Development of Roles and Responsibilities
Security Technology, Tools, and Practices
Select Topics/Deep Dives
Glossary
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Axel Wirth
holds a Master of Science in Engineering Management from Tufts University and a Bachelor of Science in Electrical, Electronics, and Communications Engineering from Düsseldorf University of Applied Sciences. He is currently the Chief Security Strategist at MedCrypt, where he has led efforts to integrate modern cybersecurity into healthcare technology since September 2019. He also serves as an Adjunct Professor at the University of Connecticut, teaching "Medical Device Cybersecurity" to graduate students.
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Christopher Gates
holds a B.S. in Computer Science from California State University. He is the Director of Product Security at Velentium, where he has been since January 2021. He previously worked as a Principal System Security Architect at Velentium, implementing Secure Development Lifecycle processes. Prior to Velentium, Christopher worked as an Embedded Security Architect and Senior Software Engineer at Illuminati Engineering.
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Jason Smith
holds a bachelor's degree in English and Religious Studies from William & Mary and a master's degree in Apologetics and Cultural Studies from Houston Baptist University. He is currently serving as a Senior Marketing Strategist at Velentium and previously worked as a Technical Writer. As a self-employed author since 2001, Jason has published an extensive collection of works, including four Amazon bestsellers, three novels, two anthologies, two memoirs, an engineering textbook, and a business book. His expertise extends to consulting on book projects and various forms of written communication, encompassing fiction, poetry, academic, technical, business, marketing, applications, and proposals.