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Report
Navigating the U.S Food & Drug Administration (FDA) Cybersecurity Requirements for Medical Devices

Overview

This whitepaper provides Director-level executives responsible for IT and cybersecurity with a comprehensive understanding of the FDA’s new cybersecurity requirements for medical devices. These requirements are intended to address the rising cyber threats targeting the healthcare sector. This paper discusses the requirements introduced by the Consolidated Appropriations Act of 2023, their implications for medical device manufacturers, and the steps necessary to ensure compliance while enhancing overall device security.

What You Get:

  • 4 key requirements from the FDA
  • Why enhanced medical device security matters
  • 6 practical steps to implementing the requirements

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Meet the Author

wolff

Cory Wolff

Director of Proactive Services

With over 20 years of experience in IT, security, and development, Cory Wolff is a passionate and skilled hacker who leads the offensive security practice at risk3sixty, a consulting firm that helps clients navigate complex cybersecurity and compliance challenges. He holds multiple certifications, including the Offensive Security Certified Professional (OSCP) and the Certified Information Systems Security Professional (CISSP), and has a proven track record of building and breaking various technologies since his first computer in 1988.

As the Director of Proactive Services, Cory oversees the delivery of high-quality penetration testing, red teaming, and vulnerability assessment services to a diverse range of clients across different industries and sectors. He also contributes to the cybersecurity community as a core team member of Red Team Village, a platform that fosters collaboration, learning, and innovation among red teamers and security professionals. Cory’s mission is to help organizations improve their security posture, protect their assets, and achieve their goals.

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