Design Failure Mode and Effects Analysis (DFMEA)

Design Failure Mode and Effects Analysis (DFMEA) - English

Design FMEA is a systematic method for identifying potential failures in a product's design by assessing their severity, occurrence, and detection and then prioritizing corrective actions to prevent design defects and ensure quality.

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Course curriculum

1. DFMEA for Medical Devices - Welcome
2. Course learning objectives
1. Learning objectives
2. Example device (Part 1)
3. Example device (Part 2)
4. Example device (Part 3)
5. Example device (Part 4)
6. Example device (Part 5)
7. Example device (Part 6)
8. Example device (Part 7)
9. Example device (Part 8)
10. QUIZ - Chapter 2
1. Learning objectives
2. DFMEA tools (Part 1)
3. DFMEA tools (Part 2)
4. DFMEA tools (Part 3)
5. DFMEA tools (Part 4)
6. DFMEA tools (Part 5)
7. DFMEA tools (Part 6)
8. FTA (Part 1)
9. FTA (Part 2)
10. FTA (Part 3)
11. FTA (Part 4)
12. FTA (Part 5)
13. FTA (Part 6)
14. SAMPLE DEVICE - FTA
15. SAMPLE DEVICE - FTA: DQS Answers
16. P-Diagram (Part 1)
17. P-Diagram (Part 2)
18. P-Diagram (Part 3)
19. P-Diagram (Part 4)
20. P-Diagram (Part 5)
21. P-Diagram (Part 6)
22. P-Diagram (Part 7)
23. P-Diagram (Part 8)
24. P-Diagram (Part 9)
25. P-Diagram (Part 10)
26. DFMEA tools summary (Part 1)
27. QUIZ - Chapter 3
28. SAMPLE DEVICE - P-Diagram
29. SAMPLE DEVICE - P-Diagram: DQS Answers
1. Learning objectives
2. DFMEA and Design V&V (Part 1)
3. DFMEA and Design V&V (Part 2)
4. DFMEA and Design V&V (Part 3)
5. DFMEA and Design V&V (Part 4)
6. DFMEA and Design V&V (Part 5)
7. DFMEA and Design Transfer
8. DFMEA and Post-Market integration
9. DFMEA Documentation
10. QUIZ - Chapter 4
11. SAMPLE DEVICE - DFMEA/Design V&V
12. SAMPLE DEVICE - DFMEA/Design V&V: DQS Answers
1. Learning objectives
2. Failure Modes (Part 1)
3. Failure Modes (Part 2)
4. Failure Modes (Part 3)
5. Failure Modes (Part 4)
6. Failure Modes (Part 5)
7. Failure Modes (Part 6)
8. QUIZ - Chapter 5
9. SAMPLE DEVICE - FAILURE MODES
10. SAMPLE DEVICE - FAILURE MODES: DQS Answers
1. Learning objectives
2. Failure Effect (Part 1)
3. Failure Effect (Part 2)
4. Failure Effect (Part 3)
5. Failure Effect (Part 4)
6. Failure Effect (Part 5)
7. Failure Effect (Part 6)
8. QUIZ - Chapter 6
9. SAMPLE DEVICE - FAILURE EFFECTS
10. SAMPLE DEVICE - FAILURE EFFECTS: DQS Answers
1. Learning objectives
2. Potential Failure Cause (Part 1)
3. Potential Failure Cause (Part 2)
4. Potential Failure Cause (Part 3)
5. Potential Failure Cause (Part 4)
6. Potential Failure Cause (Part 5)
7. Potential Failure Cause (Part 6)
8. Potential Failure Cause (Part 7)
9. Potential Failure Cause (Part 8)
10. QUIZ - Chapter 7
11. SAMPLE DEVICE - PFC
12. SAMPLE DEVICE - PFC: DQS Answers
1. Learning objectives
2. Severity Rating (Part 1)
3. Severity Rating (Part 2)
4. Severity Rating (Part 3)
5. Severity Rating (Part 4)
6. Severity Rating (Part 5)
7. Severity Rating (Part 6)
8. Severity Rating (Part 7)
9. QUIZ - Chapter 8
10. SAMPLE DEVICE - SEVERITY
11. SAMPLE DEVICE - SEVERITY: DQS Answers
1. Learning objectives
2. Occurrence Rating (Part 1)
3. Occurrence Rating (Part 2)
4. Occurrence Rating (Part 3)
5. Occurrence Rating (Part 4)
6. Occurrence Rating (Part 5)
7. QUIZ - Chapter 9
8. SAMPLE DEVICE - OCCURRENCE
9. SAMPLE DEVICE - OCCURRENCE: DQS Answers
1. Learning objectives
2. Detection Rating (Part 1)
3. Detection Rating (Part 2)
4. Detection Rating (Part 3)
5. Detection Rating (Part 4)
6. Detection Rating (Part 5)
7. Detection Rating (Part 6)
8. Detection Rating (Part 7)
9. Detection Rating (Part 8)
10. Detection Rating (Part 9)
11. Detection Rating (Part 10)
12. Detection Rating (Part 11)
13. QUIZ - Chapter 10
14. SAMPLE DEVICE - DETECTION
15. SAMPLE DEVICE - DETECTION: DQS Answers
1. Learning objectives
2. Risk Prioritization Methods (Part 1)
3. Risk Prioritization Methods (Part 2)
4. Risk Prioritization Methods (Part 3)
5. Risk Prioritization Methods (Part 4)
6. Risk Prioritization Methods (Part 5)
7. Risk Prioritization Methods (Part 6)
8. Risk Prioritization Methods (Part 7)
9. Risk Prioritization Methods (Part 8)
10. QUIZ - Chapter 11
11. SAMPLE DEVICE - RPN
12. SAMPLE DEVICE - RPN: DQS Answers
1. Learning objectives
2. DFMEA Example: Sterile Pouch (Part 1)
3. DFMEA Example: Sterile Pouch (Part 2)
4. DFMEA Example: Sterile Pouch (Part 3)
5. DFMEA Example: Sterile Pouch (Part 4)
6. DFMEA Updates (Part 1)
7. DFMEA Updates (Part 2)
8. DFMEA Updates (Part 3)
9. DFMEA Updates (Part 4)
10. QUIZ - Chapter 12
1. Learning objectives
2. DFMEA Best Practices (Part 1)
3. DFMEA Best Practices (Part 2)
4. DFMEA Best Practices (Part 3)
5. DFMEA Best Practices (Part 4)
6. DFMEA Best Practices (Part 5)
7. QUIZ - Chapter 13
1. Design FMEA (DFMEA) Conclusion - Thank you!
2. FINAL EXAM - DFMEA
3. Medical Device Design FMEA Course Survey
1. Additional resources

About this course

$1,000.00
171 lessons
2 hours of video content
Downloadable content

Design Failure Mode and Effects Analysis (DFMEA)

Master Design FMEA for medical devices—turn potential failures into safer, more reliable designs before they ever reach a patient.

Apply systematic DFMEA tools — including Function Analysis, Component Hierarchy, Fault Tree Analysis, and Parameter Diagrams — to identify and organize potential design failures.
Identify and document Failure Modes, Failure Effects, and Potential Failure Causes using structured, measurable, and traceable language.
Assign and justify Severity, Occurrence, and Detection ratings using objective data and established rating criteria.
Apply risk prioritization methods — including RPN, AIAG-VDA Action Priority, ARPN, and the criticality matrix — to rank failure modes and allocate design improvement resources effectively.
Integrate DFMEA outputs with Design Verification and Validation planning, ISO 14971 Safety Risk Management, and post-market surveillance activities.

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Medtech Business Review awarded DQS Top Medical Device Consulting 2026

"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly." — Dr. John Salvato

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Course Flyer

We are proud of our course content, which has been forged over years of client engagements, countless interactions with regulatory agencies, and sharpened through product submissions. Click on the following link to see more.DFMEA_Course_Overview JUN26.pdf

Design Failure Mode and Effects Analysis (DFMEA) - English

Course curriculum

Welcome to Design Failure Mode and Effects Analysis (DFMEA) for Medical Devices!

Chapter 1 - FMEA Background

Chapter 2 - DFMEA examples

Chapter 3 - FMEA Tool Introduction

Chapter 4 - DFMEA and Design Verification & Validation

Chapter 5 - Failure Modes

Chapter 6 - Failure Effects

Chapter 7 - Failure Causes

Chapter 8 - Failure Effect Severity

Chapter 9 - Failure Mode Occurrence

Chapter 10 - Failure Cause Detection

Chapter 11 - Risk Prioritization Methods

Chapter 12 - DFMEA Analysis

Chapter 13 - DFMEA Best Practices and Summary

DFMEA Conclusion

DFMEA Next Steps

About this course

Design Failure Mode and Effects Analysis (DFMEA)

Discover your potential, starting today

Train with DQS

Course Flyer