The Real-World Challenges of Medical Device Cybersecurity:

Mitigating Vulnerabilities

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How Do You Navigate the Cybersecurity Maze in Medical Devices?

In the rapidly evolving landscape of medical device development, cybersecurity has catapulted to the forefront, especially with the enactment of section 524B of the FD&C PATCH Act. This pivotal legislation mandates stringent cybersecurity measures for any medical device that is capable of network communications or is embedded with software, marking a significant shift in regulatory oversight by the FDA.

The journey to compliance, however, is fraught with complexities. From identifying vulnerabilities to implementing robust fixes, the path is intricate and demands a nuanced understanding of both the problem and the solution spaces.


What will you achieve with this webinar?

In this straightforward webinar, we will dive into:

  • A Strategic Overview of Vulnerability Management: Unpack the step-by-step process to manage vulnerabilities efficiently, turning a daunting task into a manageable one.
  • Decoding Vulnerabilities: Explore the various categories of vulnerabilities that plague medical devices, from OS and kernel mode drivers to open-source and custom application software, and learn how to categorize and prioritize them for your compliance strategy.
  • Mitigation Mastery: Discover the art and science of applying effective mitigations across different layers of your medical device software, ensuring a fortified defense against potential breaches.
  • The SBOM Imperative: Gain insights into the critical role of Software Bill of Materials (SBOMs) in your cybersecurity strategy, and understand its relevance and the challenges it presents in today’s regulatory environment.
  • Cybersecurity Reporting Demystified: Navigate the complexities of cybersecurity reporting to the FDA with ease, including the adept handling of Common Vulnerabilities and Exposures (CVEs) and the strategic role of Penetration Testing in your compliance toolkit.

This webinar is designed to arm medical device developers, like you, with the knowledge and tools to not just survive but thrive in the face of stringent cybersecurity regulations.

Join Timesys and ICS to transform the way you approach medical device cybersecurity and compliance, ensuring your products are not only innovative but also secure and compliant with the latest FDA mandates.

Keynote Experts

Milton Yarberry

Milton is the Director of Medical Programs & Cybersecurity for ICS. He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers.

Maciej Halasz

Maciej Halasz, Vice President of EMEA Business Development and Technical Sales for Timesys, a Lynx Software Technologies company, has more than 25 years of experience in embedded computing with a focus on embedded Linux and real-time systems. He is the technical lead and creator of a number of Timesys-offered tools and products, the creator of Timesys University embedded Linux workshops, and the co-host of LinuxLink Radio. Throughout his career, Maciej has authored numerous embedded Linux and industry articles. Maciej holds a master’s degree in Computer Science from ENST de Bretagne, France, a master’s degree in Telecommunication Systems from Poznan University of Technology, Poland, and an MBA from the University of Pittsburgh Joseph M. Katz Graduate School of Business.