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

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102.4 B

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1 - Introduction

1. Introduction.mp4

MP4

24.8 MB

10 - Common Weaknesses in Practical ISO 14971 Implementation

2 - Basics

1. Basics.html

HTML

19.5 KB

10. Risk Control Philosophy.mp4

MP4

33.4 MB

11. Connection to Other Standards and Regulations.mp4

MP4

50.7 MB

12. Structure of ISO 14971 2019.mp4

MP4

30.1 MB

3 - General requirements for risk management systems

13. Risk management process.mp4

MP4

35 MB

14. Management responsibilities.mp4

MP4

35.2 MB

15. Competence of personell.mp4

MP4

28.7 MB

16. Risk management plan.mp4

MP4

28.3 MB

17. Risk management file.mp4

MP4

49.9 MB

2. General requirements for risk management systems.html

HTML

18.6 KB

4 - Risk analysis

18. Risk analysis process.mp4

MP4

51.8 MB

19. Intended use and reasonably foreseeable misuse.mp4

MP4

59.7 MB

20. Identification of characteristics related to safety.mp4

MP4

77.9 MB

21. Identification of hazards and hazardous situations.mp4

MP4

50.7 MB

22. Risk estimation.mp4

MP4

52.2 MB

3. Risk analysis.html

HTML

18.3 KB

5 - Risk evaluation

23. Risk evaluation.mp4

MP4

76.3 MB

4. Risk evaluation.html

HTML

17.5 KB

6 - Risk control

24. Risk control option analysis.mp4

MP4

85 MB

25. Implementation of risk control measures.mp4

MP4

58.6 MB

26. Residual risk evaluation.mp4

MP4

18.6 MB

27. Benefit-risk analysis.mp4

MP4

21.2 MB

28. Risks arising from risk control measures.mp4

MP4

47 MB

29. Completeness of risk control.mp4

MP4

39.8 MB

5. Risk control.html

HTML

18.4 KB

7 - Evaluation of overall residual risk

30. Evaluation of overall residual risk.mp4

MP4

44.4 MB

6. Evaluation of overall residual risk.html

HTML

17.6 KB

8 - Risk management review

31. Risk management review.mp4

MP4

46.5 MB

7. Risk management review.html

HTML

17.6 KB

9 - Production and post-production activities

32. General.mp4	MP4	35.1 MB
33. Information collection.mp4	MP4	29.3 MB
34. Information review.mp4	MP4	22.8 MB
35. Actions.mp4	MP4	26.5 MB
36. Thank you for your attention!.mp4	MP4	50.7 MB
8. Production and post-production activities.html	HTML	18.5 KB

4. Why Risk Management in Medical Devices is Different.mp4

MP4

38.4 MB

5. History and Evolution of ISO 14971.mp4

MP4

35.4 MB

6. What is Risk in Medical Devices.mp4

MP4

39.2 MB

7. Intended Use and Reasonably Foreseeable Misuse.mp4

MP4

39.5 MB

8. Risk Acceptability and Benefit–Risk Thinking.mp4

MP4

40.4 MB

9. The Risk Management Lifecycle.mp4

MP4

36.7 MB

37. Risk Acceptability Criteria Are Not Clearly Justified.mp4

MP4

28.6 MB

38. Risk Control Verification Focuses on Implementation, Not Effectiveness.mp4

MP4

16.1 MB

39. Benefit–Risk Analysis Is Too Generic.mp4

MP4

15 MB

40. Post-Market Information Is Not Fully Integrated.mp4

MP4

13.5 MB

41. Hazard Identification Is Too Narrowly Framed.mp4

MP4

21.6 MB

2. Agenda.mp4

MP4

25.8 MB

3. Motivation.mp4

MP4

138.6 MB

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

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