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

Both new and legacy medical devices are facing an array of cybersecurity challenges.

Recently, we partnered with Critical Software to deliver a webinar discussing these challenges and the strategies manufacturers can take to secure embedded software in everything from MRI machines to infusion pumps. 

During the webinar, “Navigating FDA and EU MDR/IVDR Compliance: Cybersecurity Strategies for Medical Devices,” industry experts Doug Britton and Afonso Neto shared a comprehensive look at medical device cybersecurity and provided attendees with actionable takeaways on this crucial topic.

The discussion included:

  • In-depth analysis of FDA and EU MDR/IVDR cybersecurity requirements for medical devices
  • Effective strategies for securing both new and legacy medical devices
  • Best practices for balancing security implementation with device functionality and development processes
  • The importance of transparency in device security capabilities and limitations
  • Approaches to lifecycle management of medical device cybersecurity

To illustrate the real-world impact of these strategies, we’re offering an exclusive medical device customer use case for download. This case study showcases significant improvements in vulnerability reduction:

  • 44% reduction in overall vulnerabilities
  • 71% mitigation of the most critical vulnerabilities
  • 100% elimination of memory safety vulnerabilities exploitable at runtime

[Download the Use Case Here]

By combining RunSafe’s expertise with Critical Software’s insights, we aimed to provide a comprehensive view of the challenges and solutions in this rapidly evolving domain.

Don’t miss out on these valuable resources that can enhance your cybersecurity strategies and help protect your medical devices from emerging threats

Download our Webinar

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