Cybersecurity Risk Management for Medical Devices

Medical Device Cybersecurity Risk Management - English

Cybersecurity risk management for medical devices is the systematic process of identifying, analyzing, evaluating, and controlling risks related to cyber attacks, data breaches, and unauthorized access to medical device systems.

Course curriculum

1. Welcome!
2. Course Objectives
1. Learning Objectives
2. Cybersecurity Definitions (Part 1)
3. Cybersecurity Definitions (Part 2)
4. Cybersecurity Introduction (Part 1)
5. Cybersecurity Introduction (Part 2)
6. Cybersecurity Introduction (Part 3)
7. Cybersecurity Introduction (Part 4)
8. Cybersecurity Introduction (Part 5)
9. Cybersecurity Regulations and Guidance: US (Part 1)
10. Cybersecurity Regulations and Guidance: US (Part 2)
11. Cybersecurity Regulations and Guidance: US (Part 3)
12. Cybersecurity Regulations and Guidance: US (Part 4)
13. Cybersecurity Regulations and Guidance: US (Part 5)
14. Cybersecurity Regulations and Guidance: US (Part 6)
15. Cybersecurity Regulations and Guidance: US (Part 7)
16. Cybersecurity Regulations and Guidance: US (Part 8)
17. Cybersecurity Regulations and Guidance: US (Part 9)
18. Cybersecurity Regulations and Guidance: US (Part 10)
19. Cybersecurity Regulations and Guidance: US (Part 11)
20. Cybersecurity Regulations and Guidance: US (Part 12)
21. Cybersecurity Regulations and Guidance: US (Part 13)
22. Cybersecurity Regulations and Guidance: EU (Part 1)
23. Cybersecurity Regulations and Guidance: EU (Part 2)
24. Cybersecurity Regulations and Guidance: EU (Part 3)
25. Cybersecurity Regulations and Guidance: EU (Part 4)
26. Cybersecurity Regulations and Guidance: EU (Part 5)
27. Cybersecurity Regulations and Guidance: EU (Part 6)
28. Cybersecurity Regulations and Guidance: EU (Part 7)
29. Cybersecurity Regulations and Guidance: EU (Part 8)
30. Cybersecurity Regulations and Guidance: EU (Part 9)
31. Cybersecurity Regulations and Guidance: EU (Part 10)
32. Cybersecurity Regulations and Guidance: Other (Part 1)
33. Cybersecurity Regulations and Guidance: Other (Part 2)
34. Cybersecurity Regulations and Guidance: Other (Part 3)
35. Cybersecurity Regulations and Guidance: Other (Part 4)
36. Cybersecurity Regulations and Guidance: Other (Part 5)
37. Cybersecurity Regulations and Guidance: Other (Part 6)
38. Cybersecurity Regulations and Guidance: Other (Part 7)
39. QUIZ - CYBERSECURITY REGULATIONS
1. Learning Objectives
2. Design and Development (Part 1)
3. Design and Development (Part 2)
4. Design and Development (Part 3)
5. Design and Development (Part 4)
6. Design and Development (Part 5)
7. Design and Development (Part 6)
8. Design and Development (Part 7)
9. Design and Development (Part 8)
10. Design and Development (Part 9)
11. Design and Development (Part 10)
12. Design and Development (Part 11)
13. Design and Development (Part 12)
14. Design and Development (Part 13)
15. Design and Development (Part 14)
16. Design and Development (Part 15)
17. Design and Development (Part 16)
18. Design and Development (Part 17)
19. Design and Development (Part 18)
20. Design and Development (Part 19)
21. Design and Development (Part 20)
22. Design and Development (Part 21)
23. QUIZ - DESIGN AND DEVELOPMENT
24. Software Development (Part 1)
25. Software Development (Part 2)
26. Software Development (Part 3)
27. Software Development (Part 4)
28. Software Development (Part 5)
29. Software Development (Part 6)
30. Software Development (Part 7)
31. Software Development (Part 8)
32. Software Development (Part 9)
33. Software Development (Part 10)
34. Software Development (Part 11)
35. Software Development (Part 12)
36. Software Development (Part 13)
37. Software Development (Part 14)
38. Software Development (Part 15)
39. Software Development (Part 16)
40. Software Development (Part 17)
41. Software Development (Part 18)
42. Software Development (Part 19)
43. Software Development (Part 20)
44. Software Development (Part 21)
45. Software Development (Part 22)
46. Software Development (Part 23)
47. QUIZ - SOFTWARE DEVELOPMENT
1. Learning Objectives
2. Secure Product Development Framework (SPDF) (Part 1)
3. Secure Product Development Framework (SPDF) (Part 2)
4. Secure Product Development Framework (SPDF) (Part 3)
5. Secure Product Development Framework (SPDF) (Part 4)
6. Secure Product Development Framework (SPDF) (Part 5)
7. Secure Product Development Framework (SPDF) (Part 6)
8. Secure Product Development Framework (SPDF) (Part 7)
9. Secure Product Development Framework (SPDF) (Part 8)
10. Secure Product Development Framework (SPDF) (Part 9)
11. Secure Product Development Framework (SPDF) (Part 10)
12. Secure Product Development Framework (SPDF) (Part 11)
13. PRACTICE DEVICE – DESIGN REQUIREMENTS
14. PRACTICE DEVICE - DQS ANSWER REVIEW
15. QUIZ - SPDF
1. Learning Objectives
2. Cybersecurity Risk Management (CRM) Basics (Part 1)
3. Cybersecurity Risk Management (CRM) Basics (Part 2)
4. Cybersecurity Risk Management (CRM) Basics (Part 3)
5. Cybersecurity Risk Management (CRM) Basics (Part 4)
6. Threat Modeling (Part 1)
7. Threat Modeling (Part 2)
8. Threat Modeling (Part 3)
9. Threat Modeling (Part 4)
10. Threat Modeling (Part 6)
11. Threat Modeling (Part 7)
12. Threat Modeling (Part 8)
13. Threat Modeling (Part 9)
14. Threat Modeling (Part 10)
15. Threat Modeling (Part 11)
16. Threat Modeling (Part 12)
17. Threat Modeling (Part 13)
18. Threat Modeling (Part 14)
19. Threat Modeling (Part 15)
20. Threat Modeling (Part 16)
21. Threat Modeling (Part 17)
22. Threat Modeling (Part 18)
23. Threat Modeling (Part 19)
24. PRACTICE DEVICE – THREAT MODEL
25. PRACTICE DEVICE - DQS ANSWER REVIEW
26. QUIZ – THREAT MODEL
1. Learning Objectives
2. Network Diagram (Part 1)
3. Network Diagram (Part 2)
4. Network Diagram (Part 3)
5. Cybersecurity Architecture (Part 1)
6. Cybersecurity Architecture (Part 2)
7. Cybersecurity Architecture (Part 3)
8. Cybersecurity Architecture (Part 4)
9. Cybersecurity Architecture (Part 5)
10. Cybersecurity Architecture (Part 6)
11. Cybersecurity Architecture (Part 7)
12. Cybersecurity Architecture (Part 8)
13. Cybersecurity Architecture (Part 9)
14. Cybersecurity Architecture (Part 10)
15. Cybersecurity Architecture (Part 11)
16. Cybersecurity Architecture (Part 12)
17. Cybersecurity Architecture (Part 13)
18. PRACTICE DEVICE – NETWORK DIAGRAM & SECURITY ARCHITECTURE
19. PRACTICE DEVICE - DQS ANSWER REVIEW
20. QUIZ – NETWORK DIAGRAM & SECURITY ARCHITECTURE
1. Learning Objectives
2. Cybersecurity Evaluation Definitions (Part 1)
3. Cybersecurity Evaluations (Part 1)
4. Cybersecurity Evaluations (Part 2)
5. Cybersecurity Evaluations (Part 3)
6. Cybersecurity Evaluations (Part 4)
7. Cybersecurity Evaluations (Part 5)
8. Cybersecurity Evaluations (Part 6)
9. Cybersecurity Evaluations (Part 7)
10. Cybersecurity Evaluations (Part 8)
11. Cybersecurity Evaluations (Part 9)
12. Cybersecurity Evaluations (Part 10)
13. Cybersecurity Evaluations (Part 11)
14. PRACTICE DEVICE – CYBERSECURITY EVALUATIONS
15. PRACTICE DEVICE - DQS ANSWER REVIEW
16. QUIZ – CYBERSECURITY EVALUATIONS
1. Learning Objectives
2. Software Bill of Materials (SBOM) (Part 1)
3. Software Bill of Materials (SBOM) (Part 2)
4. Software Bill of Materials (SBOM) (Part 3)
5. Software Bill of Materials (SBOM) (Part 4)
6. Software Bill of Materials (SBOM) (Part 5)
7. Software Bill of Materials (SBOM) (Part 6)
8. Software Bill of Materials (SBOM) (Part 7)
9. Software Bill of Materials (SBOM) (Part 8)
10. Software Bill of Materials (SBOM) (Part 9)
11. Software Bill of Materials (SBOM) (Part 10)
12. Software Bill of Materials (SBOM) (Part 11)
13. Software Bill of Materials (SBOM) (Part 12)
14. Software Bill of Materials (SBOM) (Part 13)
15. Software Bill of Materials (SBOM) (Part 14)
16. Software Bill of Materials (SBOM) (Part 15)
17. QUIZ - SOFTWARE BILL OF MATERIALS (SBOM)
18. SPDF Key Points (Part 1)
19. SPDF Key Points (Part 2)
20. SPDF Key Points (Part 3)
1. Learning Objectives
2. Cybersecurity Risk Management (CRM) Introduction (Part 1)
3. Cybersecurity Risk Management (CRM) Introduction (Part 2)
4. Cybersecurity Risk Management (CRM) Introduction (Part 3)
5. Cybersecurity Risk Management (CRM) Introduction (Part 4)
6. Cybersecurity Risk Management (CRM) Introduction (Part 5)
7. Cybersecurity Risk Management (CRM) Introduction (Part 6)
8. Cybersecurity Risk Management (CRM) Introduction (Part 7)
9. Cybersecurity Risk Management (CRM) Introduction (Part 8)
10. CIA Triad (Part 1)
11. CIA Triad (Part 2)
12. CIA Triad (Part 3)
13. CIA Triad (Part 4)
14. CIA Triad (Part 5)
15. PRACTICE DEVICE – CIA
16. PRACTICE DEVICE - DQS ANSWER REVIEW
17. QUIZ – CRM INTRODUCTION AND CIA
1. Learning Objectives
2. Safety Risk Management (RM) Definitions (Part 1)
3. Safety Risk Management (RM) Definitions (Part 2)
4. Safety Risk Management (RM) Definitions (Part 3)
5. Safety Risk Management (RM) Overview (Part 1)
6. Safety Risk Management (RM) Overview (Part 2)
7. Safety Risk Management (RM) Overview (Part 3)
8. Safety Risk Management (RM) Overview (Part 4)
9. Safety Risk Management (RM) Overview (Part 5)
10. Safety Risk Management (RM) Overview (Part 6)
11. IEC/TR 80002-1 Overview (Part 1)
12. IEC/TR 80002-1 Overview (Part 2)
13. IEC/TR 80002-1 Overview (Part 3)
14. IEC/TR 80002-1 Overview (Part 4)
15. IEC/TR 80002-1 Overview (Part 5)
16. IEC/TR 80002-1 Overview (Part 6)
17. IEC/TR 80002-1 Overview (Part 7)
18. PRACTICE DEVICE – SAFETY RISK MANAGEMENT
19. PRACTICE DEVICE - DQS ANSWER REVIEW
20. QUIZ – SAFETY RISK MANAGEMENT
1. Learning Objectives
2. Cybersecurity Risk Management (CRM) Definitions (Part 1)
3. Cybersecurity Risk Management (CRM) Definitions (Part 2)
4. Cybersecurity Risk Management (CRM) Definitions (Part 3)
5. Cybersecurity Risk Management (CRM) (Part 1)
6. Cybersecurity Risk Management (CRM) (Part 2)
7. Cybersecurity Risk Management (CRM) (Part 3)
8. Cybersecurity Risk Management (CRM) (Part 4)
9. Cybersecurity Risk Management (CRM) (Part 5)
10. Cybersecurity Risk Management (CRM) (Part 6)
11. Cybersecurity Risk Management (CRM) (Part 7)
12. Cybersecurity Risk Management (CRM) (Part 8)
13. Cybersecurity Risk Management (CRM) (Part 9)
14. Cybersecurity Risk Management (CRM) (Part 10)
15. Cybersecurity Risk Management (CRM) (Part 11)
16. Cybersecurity Risk Management (CRM) (Part 12)
17. Cybersecurity Risk Management (CRM) (Part 13)
18. Cybersecurity Risk Management (CRM) (Part 14)
19. Cybersecurity Risk Management (CRM) (Part 15)
20. Cybersecurity Risk Management (CRM) (Part 16)
21. Cybersecurity Risk Management (CRM) (Part 17)
22. Cybersecurity Risk Management (CRM) (Part 18)
23. Cybersecurity Risk Management (CRM) (Part 19)
24. Cybersecurity Risk Management (CRM) (Part 20)
25. Cybersecurity Risk Management (CRM) (Part 21)
26. Cybersecurity Risk Management (CRM) (Part 22)
27. PRACTICE DEVICE - CYBERSECURITY RISK MANAGEMENT
28. PRACTICE DEVICE - DQS ANSWER REVIEW
29. QUIZ - CYBERSECURITY RISK MANAGEMENT
1. Learning Objectives
2. Common Vulnerability Scoring System (CVSS) (Part 1)
3. Common Vulnerability Scoring System (CVSS) (Part 2)
4. Common Vulnerability Scoring System (CVSS) (Part 3)
5. Common Vulnerability Scoring System (CVSS) (Part 4)
6. Common Vulnerability Scoring System (CVSS) (Part 5)
7. Common Vulnerability Scoring System (CVSS) (Part 6)
8. Common Vulnerability Scoring System (CVSS) (Part 7)
9. Common Vulnerability Scoring System (CVSS) (Part 8)
10. Common Vulnerability Scoring System (CVSS) (Part 9)
11. Common Vulnerability Scoring System (CVSS) (Part 10)
12. Common Vulnerability Scoring System (CVSS) (Part 11)
13. Common Vulnerability Scoring System (CVSS) (Part 12)
14. Common Vulnerability Scoring System (CVSS) (Part 13)
15. Common Vulnerability Scoring System (CVSS) (Part 14)
16. Common Vulnerability Scoring System (CVSS) (Part 15)
17. Common Vulnerability Scoring System (CVSS) (Part 16)
18. Common Vulnerability Scoring System (CVSS) (Part 17)
19. Common Vulnerability Scoring System (CVSS) (Part 18)
20. Common Vulnerability Scoring System (CVSS) (Part 19)
21. Common Vulnerability Scoring System (CVSS) (Part 20)
22. Common Vulnerability Scoring System (CVSS) (Part 21)
23. Common Vulnerability Scoring System (CVSS) (Part 22)
24. Common Vulnerability Scoring System (CVSS) (Part 23)
25. Common Vulnerability Scoring System (CVSS) (Part 24)
26. CVSS EXAMPLE
27. QUIZ - COMMON VULNERABILITY SCORING SYSTEM (CVSS)
1. Learning Objectives
2. Evidence Capture (Part 1)
3. Evidence Capture (Part 2)
4. Evidence Capture (Part 3)
5. Evidence Capture (Part 4)
6. Evidence Capture (Part 5)
7. Evidence Capture (Part 6)
8. Evidence Capture (Part 7)
9. Evidence Capture (Part 8)
10. Evidence Capture (Part 9)
11. Evidence Capture (Part 10)
12. Evidence Capture (Part 11)
13. Evidence Capture (Part 12)
14. QUIZ - EVIDENCE CAPTURE
15. Other Cybersecurity RCM (Part 1)
16. Other Cybersecurity RCM (Part 2)
17. Other Cybersecurity RCM (Part 3)
18. Other Cybersecurity RCM (Part 4)
19. Other Cybersecurity RCM (Part 5)
20. Trusted Input (Part 1)
21. Trusted Input (Part 2)
22. Trusted Input (Part 3)
23. Trusted Input (Part 4)
24. Trusted Input (Part 5)
25. Patient Record Integrity (Part 1)
26. Patient Record Integrity (Part 2)
27. Patient Record Integrity (Part 3)
28. Patient Record Integrity (Part 4)
29. Patient Record Integrity (Part 5)
30. Patient Record Integrity (Part 6)
31. PRACTICE DEVICE - CYBERSECURITY RISK CONTROL MEASURES (RCM)
32. PRACTICE DEVICE - DQS ANSWER REVIEW
33. QUIZ - CYBERSECURITY RISK CONTROL MEASURES (RCM)
1. Learning Objectives
2. Vulnerability Collaboration (Part 1)
3. Vulnerability Collaboration (Part 2)
4. Vulnerability Collaboration (Part 3)
5. Vulnerability Collaboration (Part 4)
6. Vulnerability Collaboration (Part 5)
7. Vulnerability Collaboration (Part 6)
8. Vulnerability Collaboration (Part 7)
9. QUIZ - VULNERABILITY COLLABORATION
10. Vulnerability Disclosure (Part 1)
11. Vulnerability Disclosure (Part 2)
12. Vulnerability Disclosure (Part 3)
13. Vulnerability Disclosure (Part 4)
14. Vulnerability Disclosure (Part 5)
15. Vulnerability Disclosure (Part 6)
16. Vulnerability Disclosure (Part 7)
17. Vulnerability Disclosure (Part 8)
18. Vulnerability Disclosure (Part 9)
19. Vulnerability Disclosure (Part 10)
20. Vulnerability Disclosure (Part 11)
21. Vulnerability Disclosure (Part 12)
22. Vulnerability Disclosure (Part 13)
23. Vulnerability Disclosure (Part 14)
24. Vulnerability Disclosure (Part 15)
25. Vulnerability Disclosure (Part 16)
26. Vulnerability Disclosure (Part 17)
27. Vulnerability Disclosure (Part 18)
28. Vulnerability Disclosure (Part 19)
29. Vulnerability Disclosure (Part 20)
30. QUIZ - VULNERABILITY DISCLOSURE
31. Cybersecurity and Device Updates (Part 1)
32. Cybersecurity and Device Updates (Part 2)
33. Cybersecurity and Device Updates (Part 3)
34. Cybersecurity and Device Updates (Part 4)
35. Cybersecurity and Device Updates (Part 5)
36. Cybersecurity and Device Updates (Part 6)
37. Cybersecurity and Device Updates (Part 7)
38. Cybersecurity and Device Updates (Part 8)
39. Cybersecurity and Device Updates (Part 9)
40. Cybersecurity and Device Updates (Part 10)
41. Cybersecurity and Device Updates (Part 11)
42. Cybersecurity and Device Updates (Part 12)
43. Cybersecurity and Device Updates (Part 13)
44. QUIZ - CYBERSECURITY UPDATES
1. CRM - Thank you!
2. CRM Final Exam
1. CRM Additional resources
2. CRM Course Survey

About this course

$3,500.00
359 lessons
3 hours of video content
Downloadable content

Medical Device Cybersecurity Risk Management (CRM)

CRM for medical devices is the systematic process of identifying, analyzing, evaluating, and controlling risks related to cyber attacks, data breaches, and unauthorized access to medical device systems. Global regulators have emphasized CRM as essential for ensuring patient safety and product functionality. Medical devices increasingly contain software, wireless connectivity, and cloud interfaces, which expand their attack surface and potential vulnerabilities. A successful cyber attack could compromise device operation, corrupt patient data, enable unauthorized modifications to treatment parameters, or create patient safety hazards.

Analyze and apply regulatory requirements for cybersecurity in medical devices across multiple jurisdictions and integrate these requirements into design controls and product development processes.
Implement a Secure Product Development Framework (SPDF) that integrates cybersecurity considerations throughout the entire design control process, including threat modeling, security architecture development, and risk management activities.
Conduct comprehensive threat modeling using established methodologies to systematically identify security vulnerabilities, threats, and assets within medical device systems.
Execute cybersecurity risk assessments using standardized approaches to evaluate threats, vulnerabilities, and impacts through the CIA triad.
Design layered security architectures with effective risk control measures including authentication, authorization, encryption, evidence capture systems, trusted input validation, and patient record integrity protection.
Develop multi-layered cybersecurity evaluation strategies including penetration testing, vulnerability assessments, fuzz testing, and code reviews to validate security control effectiveness.
Create and maintain Software Bills of Materials (SBOMs) to ensure supply chain transparency, manage third-party software risks, and support vulnerability management.
Integrate cybersecurity into Software Development Life Cycle (SDLC) processes, including proper configuration management, traceability, and problem resolution.
Establish postmarket cybersecurity management processes including coordinated vulnerability disclosure, stakeholder communication, secure update mechanisms, and participation in Information Sharing Analysis Organizations (ISAOs).

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Medical Device Cybersecurity Risk Management - English

Course curriculum

Welcome to Cybersecurity Risk Management (CRM)

Chapter 1: Cybersecurity Guidance and Regulations

Chapter 2: Cybersecurity and Product Development Overview

Chapter 3: Secure Product Development Framework (SPDF)

Chapter 4: Threat Modeling

Chapter 5: Network Diagrams and Cybersecurity Architecture

Chapter 6: Cybersecurity Evaluations

Chapter 7: Software Bill of Materials (SBOM)

Chapter 8: Cybersecurity Risk Management (CRM)

Chapter 9: Safety Risk Management Overview

Chapter 10: Cybersecurity Risk Management (CRM)

Chapter 11: Common Vulnerability Scoring System (CVSS)

Chapter 12: Cybersecurity Risk Control Measures (RCM)

Chapter 13: Post Market Cybersecurity

Cybersecurity Risk Management (CRM) Conclusion

Next steps

About this course

Medical Device Cybersecurity Risk Management (CRM)

Discover your potential, starting today

Welcome to Cybersecurity Risk Management (CRM)

Chapter 1: Cybersecurity Guidance and Regulations

Chapter 2: ​Cybersecurity and Product Development Overview

Chapter 3: Secure Product Development Framework (SPDF)

Chapter 4: Threat Modeling

Chapter 5: Network Diagrams and Cybersecurity Architecture

Chapter 6: Cybersecurity Evaluations

Chapter 7: Software Bill of Materials (SBOM)

Chapter 8: Cybersecurity Risk Management (CRM)

Chapter 9: Safety Risk Management Overview

Chapter 10: Cybersecurity Risk Management (CRM)

Chapter 11: Common Vulnerability Scoring System (CVSS)

Chapter 12: Cybersecurity Risk Control Measures (RCM)

Chapter 13: Post Market Cybersecurity

Cybersecurity Risk Management (CRM) Conclusion

Next steps

About this course

Chapter 2: Cybersecurity and Product Development Overview