New Course

This work instruction was updated to the 2025 FDA guidance and expanded from 19 to 37 pages. This is sold as a webinar bundle providing detailed instructions and templates for compliance with the 2025 Guidance from the FDA on cybersecurity of device pre-market submissions. You will receive detailed instructions explaining how to complete the templates provided with the cybersecurity work instruction, what order the templates should be used, and the “shift left” approach needed to comply with the new 2025 FDA cybersecurity guidance.

About the course

Includes: - WI-007, Cybersecurity Work Instruction - Webinar and Slides - TMP-058 Cybersecurity Risk Management Report - TMP-064 Threat Modelling Template - TMP-043 Cybersecurity Risk Assessment - TMP-051 Software Bill of Materials (SBOM) - TMP-059 Software Level of Support and End of Support - TMP-063 Safety and Security Assessment of Vulnerabilities - TMP-048 Unresolved Anomalies - TMP-060 Cybersecurity Controls - TMP-052 Security Architecture - TMP-067 Cybersecurity Metrics - TMP-056 Vulnerability Management Plan

Curriculum

1 Chapter · 15 Lessons

1
1. (Included in full purchase)
  WI-007: Cybersecurity Work Instruction Webinar
2. (Included in full purchase)
  WI-007: Cybersecurity Work Instruction Webinar (Slides)
3. (Included in full purchase)
  WI-007: Cybersecurity Work Instruction
4. (Included in full purchase)
  TMP-058: Cybersecurity Risk Management Report
5. (Included in full purchase)
  TMP-064: Threat Modelling Template
6. (Included in full purchase)
  TMP-043 Cybersecurity Risk Assessment
7. (Included in full purchase)
  TMP-051: Software Bill of Materials (SBOM)
8. (Included in full purchase)
  TMP-059: Software Level of Support and End of Support
9. (Included in full purchase)
  TMP-063: Safety and Security Assessment of Vulnerabilities
10. (Included in full purchase)
  TMP-048: Unresolved Anomalies
11. (Included in full purchase)
  TMP-060: Cybersecurity Controls
12. (Included in full purchase)
  TMP-052: Security Architecture
13. (Included in full purchase)
  TMP-067: Cybersecurity Metrics
14. (Included in full purchase)
  TMP-056: Vulnerability Management Plan
15. (Included in full purchase)
  Support Material: NIST 800-30

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