This book 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 business and patient exposure to cybersecurity risks. It represents a complete guide for medical device manufacturers seeking to implement cybersecurity lifecycle processes across their premarket and postmarket activities. This step-by-step guide explains the implementation of security best practices in accordance with industry standards and expectations, advising readers about the full range of topics from high-level concepts to real-world solutions and tools. It spotlights the security activities of every lifecycle phase of a product, including concept, design, implementation, supply chain, manufacturing, postmarket maintenance, and end of life.
Reflecting rapid industry developments, regulatory changes, and technology advances, this second edition provides essential updates and new content to bring readers' knowledge up to date. Thanks to contributions from topic experts across public and private sectors, including Kevin Fu, Greg Garcia, Shannon Lantzy, Eric Henry, David Finn, Sherri Douville, William Harding, Dennis Seymour, Allan Friedman, Ken Hoyme, Eric Pancoast, and Mike Kijewski, this new edition is an indispensable resource for a wide range of professionals involved in medical device manufacturing and procurement, including engineering management, software/firmware engineers, business managers, regulatory professionals, contract manufacturers, regulators, product/project managers, sales, and marketing.
Axel Wirth holds a master of science in engineering management from the Gordon Institute at 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 clinical engineering graduate students.
