This guide explains medical device cybersecurity for medical device manufacturers and engineers. It details how to incorporate secure development practices into the development lifecycle and addresses the foundational steps related to governance and organization, regulation, the supply chain, and general practices; supply chain management aspects; security in the medical device manufacturer development cycle, production and sales, and the postmarket lifecycle; aspects of the healthcare delivery organization lifecycle; documentation and security artifacts; the organizational development of roles and responsibilities; and security technology, tools, and practices. Wirth is a security strategist with experience in the medical device, healthcare information technology, and cybersecurity industries; Gates is a systems security architect with experience in medical device design; and Smith is a marketing strategist and technical writer. Annotation �2020 Ringgold, Inc., Portland, OR (protoview.com)

About the Author

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.

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.

Jason Smith is a marketing strategist and technical writer at Velentium. He received his MA from Houston Baptist University.

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