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Cybersecurity in Medical Devices:
Practical Advice for FDA’s 510(k) Requirements

Medical Device Cyber Testing

November 14, 2024 | 1 pm EST

 
Cybersecurity in medical devices isn’t just important—it’s mandatory. The FDA now requires rigorous cybersecurity testing for devices, going beyond standard software checks. This includes your medical device, cloud, and applications running on smart phones/tablets. Their guidelines outline specific tests designed to ensure device safety, effectiveness, and security. As the FDA puts it, “Cybersecurity controls require testing beyond software verification and validation.”

But what makes cybersecurity testing different? 

It’s more than just verifying inputs and outputs. Validation is where cybersecurity takes a different path. Often, security requirements are unclear or incomplete, which can leave gaps. That’s why specialized tests—Threat Mitigation, Vulnerability Testing, and Penetration Testing (Pentesting)—are key to securing your devices.

 In this webinar, you’ll learn:

  • Why cybersecurity testing is different from standard software testing
  • The specific types of tests the FDA expects
  • What is the difference between fuzzing and scanning
  • Review of an effective penetration testing methodology
Stay ahead of emerging threats by mastering the FDA’s cybersecurity requirements and taking a defense in depth approach to cybersecurity testing.

Don’t leave your devices vulnerable. Secure them now!

To register, please submit the form:

About The Presenters

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Milton Yarberry
ICS

Milton is the Director of Medical Programs 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.

Colin Duggan
BG Networks

Colin is the founder and CEO of BG Networks. Before founding BG Networks in 2020, Colin worked at Analog Devices for 29 years in various engineering, management, and marketing leadership roles managing teams located in U.S., China, Europe, and India. Colin’s experience includes work in automotive, consumer, industrial, and medical markets.

Jarret Raim
HackerOne

Jarret Raim is a product and engineering leader in the security and Cloud space. He is currently the VP of Product for Assessments at HackerOne where he owns products and services that customers use to find high-fidelity, complex vulnerabilities in their platforms and meet their compliance obligations. He has previously served as a CISO and security product leader at Mission Cloud Services as well as founding and launching two Managed Detection and Response offerings at Bitdefender and Rackspace.