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FDA Medical Device Cybersecurity Compliance Checklist

Navigating the complexities of FDA Medical Device Cybersecurity Compliance is a daunting task for healthcare organizations. Our comprehensive guide simplifies this process, offering actionable insights and expert advice to help you achieve compliance and ensure the safety of your medical devices.

What’s Inside?

  • Understanding FDA’s Cybersecurity Guidelines: A deep dive into what the FDA expects from healthcare organizations.
  • Security Risk Management: Strategies for threat modeling, third-party software, and documentation.
  • Security Architecture: An overview of implementing robust security controls.
  • Cybersecurity Testing: The importance of regular testing and how penetration testing can help.
  • Software Bill of Materials (SBOM): What it is and why it’s crucial for managing cybersecurity risks.
  • Postmarket Management of Cybersecurity: How to continue managing cybersecurity risks after your medical device is on the market.

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