Udemy - Overview - Medical Devices (ISO 14971 - 2019)

  • CategoryOther
  • TypeTutorials
  • LanguageEnglish
  • Total size1.7 GB
  • Uploaded Byfreecoursewb
  • Downloads22
  • Last checkedFeb. 28th '26
  • Date uploadedFeb. 27th '26
  • Seeders 3
  • Leechers8

Infohash : 48BED81FD23573EDDBC9A4D5F51103FA27EEC7AA

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

Files:

[ WebToolTip.com ] Udemy - Overview - Medical Devices (ISO 14971 - 2019)
  • Get Bonus Downloads Here.url (0.2 KB)
    • ~Get Your Files Here ! 1 - Introduction
    • 1. Introduction.mp4 (24.8 MB)
    • 2. Agenda.mp4 (25.8 MB)
    • 3. Motivation.mp4 (138.6 MB)
    10 - Common Weaknesses in Practical ISO 14971 Implementation
    • 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 (15.0 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 - 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)
    • 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)
    3 - General requirements for risk management systems
    • 13. Risk management process.mp4 (35.0 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 (85.0 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 (47.0 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)
    • Bonus Resources.txt (0.1 KB)

Code:

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