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.
- 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.