A Medical Device Cybersecurity Toolbox | Tools & Processes for FDA Compliance

The FDA’s cybersecurity guidance for medical devices requires both processes and technology tools to ensure products are secure by design and resilient in the field. This whitepaper explores how manufacturers can build a mature cybersecurity program that meets regulatory expectations while minimizing long-term costs and risks.Using a hypothetical device manufacturer as an example, it breaks down FDA’s premarket and postmarket recommendations, maps them to practical workflows, and highlights leading software tools — including MedCrypt — that help address the technical requirements for vulnerability management, encryption, and risk monitoring.

Cybersecurity isn’t optional in modern medical device design — it’s a regulatory expectation and a market differentiator.The FDA has made it clear that manufacturers must manage both internal and external “cybersecurity signals,” establish secure product development frameworks, and prove ongoing vigilance through postmarket surveillance. This whitepaper provides a roadmap for integrating these requirements efficiently, helping teams strike the right balance between compliance, cost-effectiveness, and patient safety.

• Engineering, R&D, and product design leaders building connected medical devices
• Regulatory and quality teams managing FDA and ISO/IEC cybersecurity compliance
• Product security officers and CISOs responsible for lifecycle vulnerability management
• Executives and program managers defining security-by-design strategy

• FDA expects both process-level and technical interventions to ensure product security.
• A mature cybersecurity program integrates secure design, continuous testing, and third-party collaboration.
• Addressing vulnerabilities early is far cheaper than reactive remediation postmarket.
• Partnerships with specialized vendors accelerate compliance and reduce engineering burden.
• MedCrypt enables secure cryptography, intrusion detection, and vulnerability monitoring aligned with FDA requirements.

1. Introduction: Why Cybersecurity Requires Both Processes and Tools
   
   1. FDA’s Postmarket and Premarket Cybersecurity Guidance
   2. Definition of “secure by design” in the context of quality systems
   3. How MedCrypt’s research with ICS-CERT informs this approach
2. Section I: Cybersecurity Processes Start During Design
   
   1. Overview of FDA’s 11 lifecycle recommendations
   2. Key process vs. product interventions
   3. Example lifecycle mapping for manufacturers
   4. Premarket vs. postmarket security requirements across development phases
3. Section II: Signals Come from Both Inside & Outside the Company
   
   1. Internal cybersecurity signals
      
      1. Static code analysis (e.g., Synopsys Coverity)
      2. Penetration testing (internal vs. third-party)
      3. Managing technical debt
      4. Change control and controlled release
   2. External cybersecurity signals
      
      1. Third-party software vulnerabilities (e.g., OpenSSL, Windows)
      2. Customer and HDO feedback loops
      3. Security researcher disclosures and the DMCA provision
      4. Coordinated vulnerability disclosure programs
4. Section III: It’s Cheaper to Secure Than to Fix
   
   1. The ROI of early-stage security investment
   2. Reducing recall and remediation costs through preventive design
   3. Common vulnerability sources (user authentication and software code errors)
      
   4. Example tools for mitigation:
      
      1. Okta (authentication)
      2. Synopsys (SCA)
      3. Digicert (PKI)
      4. MedCrypt (encryption and intrusion detection)
      5. AlienVault (vulnerability management)
5. Section IV: Conclusion — Building a Resilient Security Culture
   
   1. The business case for shared knowledge and open platforms
   2. Aligning internal and external collaboration to strengthen resilience
   3. Leveraging commercial and regulatory partnerships to scale compliance
6. Appendix A: The Medical Device Cybersecurity Toolbox
   
   1. Curated list of commercial tools used by leading MDMs, including:
      
      1. AlienVault: Vulnerability management
      2. Atlassian Jira: Bug tracking
      3. Digicert: Certificate and PKI management
      4. MedCrypt: Endpoint encryption and behavior monitoring
      5. Nova Leah: SBOM and compliance
      6. Okta: Authentication
      7. Phobos Group & WhiteScope: Penetration testing
      8. Symantec: Embedded security client
      9. Synopsys Coverity: Static code analysis