LEADER 03990nam 22005173 450 001 9911006741103321 005 20241117090255.0 010 $a9781523162598 010 $a1523162597 010 $a9781630819927 010 $a1630819921 035 $a(CKB)36517419900041 035 $a(MiAaPQ)EBC31781943 035 $a(Au-PeEL)EBL31781943 035 $a(Exl-AI)31781943 035 $a(OCoLC)1485011786 035 $a(EXLCZ)9936517419900041 100 $a20241117d2024 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aMedical Device Cybersecurity for Engineers and Manufacturers, Second Edition 205 $a2nd ed. 210 1$aNorwood :$cArtech House,$d2024. 210 4$dİ2024. 215 $a1 online resource (481 pages) 311 08$a9781630819910 311 08$a1630819913 327 $aMedical Device Cybersecurityfor Engineers and Manufacturers, Second Edition -- Contents -- Foreword to the First Edition -- Foreword to the Second Edition -- 1 Why Secure Medical Devices? -- 1.1?The Inspiration for This Book: The Original First Edition Introduction -- 1.2?Why a Second Edition? -- 1.3?The Evolution of Cybersecurity in Healthcare -- 1.4?The Unique Role of Medical Devices -- 1.5?Regulatory Environment -- 1.6?Looking Ahead -- References -- 2 Establishing a Cybersecurity Focus Within Medical Device Manufacturers -- 2.1?Governance and Organization -- 2.2?Building a Security-Capable Organization -- 2.2.1?Implementation and Oversight -- 2.2.2?A Lifecycle Approach to Cybersecurity -- 2.2.3?Design and Implementation of Best Practices and Principles -- 2.2.4?Security Testing -- 2.2.5?PostMarket Management -- 2.2.6?Internal Training for Non-Cybersecurity Engineers and Managers -- 2.3?Communicating Cybersecurity Needs, Costs, and Risks to Senior Leadership -- 2.3.1?Lack of Common Understanding of Cybersecurity Risks -- 2.3.2?Lack of Context for the Risk and Its Tradeoffs -- 2.3.3?Talking to the Wrong Leader, That Is, Not the Decision-Maker -- 2.4?Security and Lifecycle Management Overview -- 2.4.1?Coordination Between the Four Lifecycles -- 2.5?Organizational Roles and Responsibilities -- 2.5.1?Roles and Responsibilities: Overview and Rationale -- 2.5.2?Role-Specific Training and Education$7Generated by AI. 330 $aThis book focuses on the cybersecurity challenges and solutions relevant to medical device engineering and manufacturing. It provides a comprehensive guide to establishing secure practices throughout the lifecycle of medical devices, from design and development to deployment and postmarket management. Authored by Axel Wirth, Christopher Gates, and Jason Smith, the book emphasizes the importance of adhering to global regulations and standards, addressing supply chain risks, and implementing robust incident response plans. The second edition includes updates on the evolving cybersecurity landscape in healthcare, offering best practices for engineers, manufacturers, and regulatory professionals. It is intended for a professional audience, including medical device developers, security specialists, and compliance managers, aiming to enhance the security and safety of medical technologies.$7Generated by AI. 606 $aComputer security$xStandards$7Generated by AI 606 $aMedical instruments and apparatus$7Generated by AI 615 0$aComputer security$xStandards 615 0$aMedical instruments and apparatus 700 $aWirth$b Axel$01111470 701 $aGates$b Christopher$01822816 701 $aSmith$b Jason$01822817 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911006741103321 996 $aMedical Device Cybersecurity for Engineers and Manufacturers, Second Edition$94389228 997 $aUNINA