| Bonus Resources.txt | 102.4 B | ||
| Get Bonus Downloads Here.url | 204.8 B | ||
| ~Get Your Files Here ! | |||
| 1 - Introduction | |||
| 1. Introduction.mp4 | 24.8 MB | ||
| 10 - Common Weaknesses in Practical ISO 14971 Implementation | |||
| 2 - Basics | |||
| 1. Basics.html | 19.5 KB | ||
| 10. Risk Control Philosophy.mp4 | 33.4 MB | ||
| 11. Connection to Other Standards and Regulations.mp4 | 50.7 MB | ||
| 12. Structure of ISO 14971 2019.mp4 | 30.1 MB | ||
| 3 - General requirements for risk management systems | |||
| 13. Risk management process.mp4 | 35 MB | ||
| 14. Management responsibilities.mp4 | 35.2 MB | ||
| 15. Competence of personell.mp4 | 28.7 MB | ||
| 16. Risk management plan.mp4 | 28.3 MB | ||
| 17. Risk management file.mp4 | 49.9 MB | ||
| 2. General requirements for risk management systems.html | 18.6 KB | ||
| 4 - Risk analysis | |||
| 18. Risk analysis process.mp4 | 51.8 MB | ||
| 19. Intended use and reasonably foreseeable misuse.mp4 | 59.7 MB | ||
| 20. Identification of characteristics related to safety.mp4 | 77.9 MB | ||
| 21. Identification of hazards and hazardous situations.mp4 | 50.7 MB | ||
| 22. Risk estimation.mp4 | 52.2 MB | ||
| 3. Risk analysis.html | 18.3 KB | ||
| 5 - Risk evaluation | |||
| 23. Risk evaluation.mp4 | 76.3 MB | ||
| 4. Risk evaluation.html | 17.5 KB | ||
| 6 - Risk control | |||
| 24. Risk control option analysis.mp4 | 85 MB | ||
| 25. Implementation of risk control measures.mp4 | 58.6 MB | ||
| 26. Residual risk evaluation.mp4 | 18.6 MB | ||
| 27. Benefit-risk analysis.mp4 | 21.2 MB | ||
| 28. Risks arising from risk control measures.mp4 | 47 MB | ||
| 29. Completeness of risk control.mp4 | 39.8 MB | ||
| 5. Risk control.html | 18.4 KB | ||
| 7 - Evaluation of overall residual risk | |||
| 30. Evaluation of overall residual risk.mp4 | 44.4 MB | ||
| 6. Evaluation of overall residual risk.html | 17.6 KB | ||
| 8 - Risk management review | |||
| 31. Risk management review.mp4 | 46.5 MB | ||
| 7. Risk management review.html | 17.6 KB | ||
| 9 - Production and post-production activities | |||
| 32. General.mp4 | 35.1 MB | ||
| 33. Information collection.mp4 | 29.3 MB | ||
| 34. Information review.mp4 | 22.8 MB | ||
| 35. Actions.mp4 | 26.5 MB | ||
| 36. Thank you for your attention!.mp4 | 50.7 MB | ||
| 8. Production and post-production activities.html | 18.5 KB | ||
| 4. Why Risk Management in Medical Devices is Different.mp4 | 38.4 MB | ||
| 5. History and Evolution of ISO 14971.mp4 | 35.4 MB | ||
| 6. What is Risk in Medical Devices.mp4 | 39.2 MB | ||
| 7. Intended Use and Reasonably Foreseeable Misuse.mp4 | 39.5 MB | ||
| 8. Risk Acceptability and Benefit–Risk Thinking.mp4 | 40.4 MB | ||
| 9. The Risk Management Lifecycle.mp4 | 36.7 MB | ||
| 37. Risk Acceptability Criteria Are Not Clearly Justified.mp4 | 28.6 MB | ||
| 38. Risk Control Verification Focuses on Implementation, Not Effectiveness.mp4 | 16.1 MB | ||
| 39. Benefit–Risk Analysis Is Too Generic.mp4 | 15 MB | ||
| 40. Post-Market Information Is Not Fully Integrated.mp4 | 13.5 MB | ||
| 41. Hazard Identification Is Too Narrowly Framed.mp4 | 21.6 MB | ||
| 2. Agenda.mp4 | 25.8 MB | ||
| 3. Motivation.mp4 | 138.6 MB |
Overview - Medical Devices (ISO 14971:2019)
https://WebToolTip.com
Published 2/2026
Created by Alexander Walter
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Level: All Levels | Genre: eLearning | Language: English | Duration: 41 Lectures ( 2h 17m ) | Size: 1.66 GB
Medical devices — Application of risk management to medical devices
What you'll learn
✓ Explain the purpose, scope, and regulatory relevance of ISO 14971 for medical device risk management.
✓ Describe the structure and key elements of the risk management process defined in ISO 14971.
✓ Identify hazards, hazardous situations, and potential harms associated with medical devices.
✓ Understand the principles of risk analysis, risk evaluation, and risk control.
✓ Explain how risk acceptability is determined and documented within a risk management framework.
✓ Understand the concept of residual risk and the evaluation of overall residual risk.
✓ Describe the role of risk management throughout the product lifecycle, including production and post-production activities.
✓ Recognize how ISO 14971 supports communication between engineering, quality, clinical, and regulatory teams.
Requirements
● No prior knowledge required
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| 1.4 GB | freecoursewb | 6 days | 0 | 0 | |
| 1.8 GB | freecoursewb | 3 months | 0 | 0 | |
| 309.8 MB | freecoursewb | 6 months | 0 | 0 | |
| 407.9 MB | freecoursewb | 11 months | 8 | 2 | |
| 1.1 GB | freecoursewb | 1 year | 5 | 1 |
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