Christopher Gates – författare

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.

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition removes the mystery from cybersecurity engineering and regulatory processes and practices, showing medical device manufacturers how to produce and maintain devices that meet evolving regulatory expectations and reduce cybersecurity risks to business and patients. It represents a complete guide for medical device manufacturers seeking to implement lifecycle processes that secure their premarket and postmarket activities. This step-by-step guide educates manufacturers about the implementation of security best practices in accordance with industry standards and expectations, advising the reader about everything from high-level concepts to real-world solutions and tools. It focuses on the security aspects of every lifecycle phase of the product, including concept, design, implementation, supply chain, manufacturing, postmarket maintenance, and end of life. It details the practices, processes, and outputs necessary to create a secure medical device capable of gaining regulatory approval and meeting market entry requirements. Reflecting rapid industry developments, regulatory changes, and technology advances, this new edition equips manufacturers with the knowledge to produce secure products that meet regulatory and market requirements while anticipating threats from sophisticated cyber adversaries. It's an indispensable resource for a wide range of professionals involved in medical device manufacturing, including engineering management, software/firmware engineers, business managers, regulatory professionals, contract manufacturers, FDA regulators, product/project managers, sales and marketing teams, and healthcare delivery organizations.