Everything you need to know about CyberSecurity for Medical Devices

Cybersecurity Assessment and Documentation for your FDA, TGA and MDR submission

Here is a list of the essential cybersecurity documentation and artifacts you will require for your FDA, TGA, and MDR submission:

  1. Cybersecurity Risk Management Plan
  2. Cybersecurity Risk Assessment and Analysis
  3. Threat Modeling Report
  4. Vulnerability Assessment and Penetration Testing Reports
  5. Software Bill of Materials (SBOM)
  6. Security Design Documentation
  7. Access Control Measures Documentation
  8. Data Integrity and Confidentiality Measures
  9. Encryption and Key Management Documentation
  10. Secure Software Development Lifecycle (SDLC) Documentation
  11. Incident Response Plan
  12. Postmarket Cybersecurity Plan
  13. Labeling and User Documentation (including cybersecurity instructions)
  14. Third-Party Components and Services Security Documentation
Let us know if you like our team to assist with this list.
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