Navigating FDA and EU MDR/IVDR Compliance: Cybersecurity Strategies for Medical Devices

The rise of connected medical devices has increased cybersecurity risks in healthcare. FDA reports show growing vulnerabilities, highlighting the need for stronger security measures.

Date: Tuesday, November 7, 2024

Time: 10:00 AM EST

On November 7th at 10:00 AM ET, join Doug Britton (RunSafe Security) and Afonso Neto (Critical Software) to discuss protecting medical devices through cybersecurity. They’ll discuss FDA and EU MDR expectations, focusing on transparency and risk management throughout a device’s lifecycle. The speakers will share practical approaches to enhance device security for both new and legacy medical devices without disrupting existing architectures. Attendees will gain valuable insights into balancing stringent security requirements with the practical needs of manufacturers, ensuring medical technologies remain both secure and accessible.

Key Takeaways

  • Understanding FDA and EU MDR/IVDR cybersecurity requirements for medical devices
  • Strategies for securing both new and legacy medical devices
  • Balancing security implementation with device functionality and development processes
  • Importance of transparency in device security capabilities and limitations
  • Approaches to lifecycle management of medical device cybersecurity

Don’t miss this opportunity to gain valuable insights into Cybersecurity Strategies for Medical Devices.

Register now to secure your spot!

Meet Our Speakers:

Doug Britton, CSO, RunSafe Security

Doug Britton is the Chief Strategy Officer and Director at RunSafe Security, where he drives technology strategy and manages software development teams. Previously, he founded Kaprica Security, selling its Tachyon business to Samsung, and led significant security research programs at Lockheed Martin and SAIC. A trained computer scientist, Doug began his career at the National Center for Supercomputing Applications and served as a Russian Linguist in the US Army. He holds an MBA from the University of Maryland and mentors emerging entrepreneurs.

Afonso Neto, Senior Information Security Engineer, Critical Software

Dedicated Information Security and Privacy Expert with a Ph.D. in Information Security and a Master’s in Cryptography, bringing over 20 years of comprehensive experience. I have a deep expertise in all facets of cybersecurity, from strategic management and threat modeling to hands-on implementation of security controls and penetration testing. In the past two years, I’ve specialized as a product security engineer and cybersecurity consultant, focusing on medical devices. My work has centered on threat modeling, regulatory compliance (US and EU), and aligning with key industry standards, including IEC 62304, IEC 62443-4-1, IEC 60601-4-5, and IEC 81001-5-1.

Moderated by: Staci Cretu, SVP & CMO, RunSafe Security

Staci Cretu brings over 20 years of experience in integrated marketing communications. She is known for her ability to tailor unique narratives and media strategies to each brand’s unique identity and goals. She is dedicated to elevating RunSafe’s profile as a frontrunner in cybersecurity, particularly emphasizing the protection of the nation’s critical infrastructure.

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