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
is chief security strategist at MedCrypt. He received his M.S. in Engineering Management (MSEM) from The Gordon Institute of Tufts University. He has more than 30 years of experience in the medical device, healthcare IT and cybersecurity industries and is a member and workgroup participant with AAMI, HIMSS, H-ISAC, and IEEE.
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Christopher Gates
is a principal system security architect at Velentium. He received his B.S. in computer science from California State University Northridge and has over 30 years of experience in medical device design.
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Jason Smith
is a marketing strategist and technical writer at Velentium. He received his MA from Houston Baptist University.