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

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Title: Udemy - Overview - Medical Devices ISO 14971Group: 2019Source: Udemy
Info Hash
48BED81FD23573EDDBC9A4D5F51103FA27EEC7AA
Source
Unverified
Total Size
1.66 GB
Total Files
51
Seeders
2
Leechers
1
Health
1.00
Score
5
Type
Bookware

File List

FileSize
Get Bonus Downloads Here.url180 B
~Get Your Files Here !/1 - Introduction/1. Introduction.mp424.79 MB
~Get Your Files Here !/1 - Introduction/2. Agenda.mp425.82 MB
~Get Your Files Here !/1 - Introduction/3. Motivation.mp4138.65 MB
~Get Your Files Here !/10 - Common Weaknesses in Practical ISO 14971 Implementation/37. Risk Acceptability Criteria Are Not Clearly Justified.mp428.62 MB
~Get Your Files Here !/10 - Common Weaknesses in Practical ISO 14971 Implementation/38. Risk Control Verification Focuses on Implementation, Not Effectiveness.mp416.13 MB
~Get Your Files Here !/10 - Common Weaknesses in Practical ISO 14971 Implementation/39. Benefit–Risk Analysis Is Too Generic.mp415.02 MB
~Get Your Files Here !/10 - Common Weaknesses in Practical ISO 14971 Implementation/40. Post-Market Information Is Not Fully Integrated.mp413.54 MB
~Get Your Files Here !/10 - Common Weaknesses in Practical ISO 14971 Implementation/41. Hazard Identification Is Too Narrowly Framed.mp421.57 MB
~Get Your Files Here !/2 - Basics/1. Basics.html19.47 KB
~Get Your Files Here !/2 - Basics/10. Risk Control Philosophy.mp433.39 MB
~Get Your Files Here !/2 - Basics/11. Connection to Other Standards and Regulations.mp450.67 MB
~Get Your Files Here !/2 - Basics/12. Structure of ISO 14971 2019.mp430.09 MB
~Get Your Files Here !/2 - Basics/4. Why Risk Management in Medical Devices is Different.mp438.4 MB
~Get Your Files Here !/2 - Basics/5. History and Evolution of ISO 14971.mp435.45 MB
~Get Your Files Here !/2 - Basics/6. What is Risk in Medical Devices.mp439.17 MB
~Get Your Files Here !/2 - Basics/7. Intended Use and Reasonably Foreseeable Misuse.mp439.53 MB
~Get Your Files Here !/2 - Basics/8. Risk Acceptability and Benefit–Risk Thinking.mp440.43 MB
~Get Your Files Here !/2 - Basics/9. The Risk Management Lifecycle.mp436.67 MB
~Get Your Files Here !/3 - General requirements for risk management systems/13. Risk management process.mp434.97 MB
~Get Your Files Here !/3 - General requirements for risk management systems/14. Management responsibilities.mp435.21 MB
~Get Your Files Here !/3 - General requirements for risk management systems/15. Competence of personell.mp428.69 MB
~Get Your Files Here !/3 - General requirements for risk management systems/16. Risk management plan.mp428.26 MB
~Get Your Files Here !/3 - General requirements for risk management systems/17. Risk management file.mp449.92 MB
~Get Your Files Here !/3 - General requirements for risk management systems/2. General requirements for risk management systems.html18.56 KB
~Get Your Files Here !/4 - Risk analysis/18. Risk analysis process.mp451.75 MB
~Get Your Files Here !/4 - Risk analysis/19. Intended use and reasonably foreseeable misuse.mp459.74 MB
~Get Your Files Here !/4 - Risk analysis/20. Identification of characteristics related to safety.mp477.92 MB
~Get Your Files Here !/4 - Risk analysis/21. Identification of hazards and hazardous situations.mp450.66 MB
~Get Your Files Here !/4 - Risk analysis/22. Risk estimation.mp452.23 MB
~Get Your Files Here !/4 - Risk analysis/3. Risk analysis.html18.28 KB
~Get Your Files Here !/5 - Risk evaluation/23. Risk evaluation.mp476.26 MB
~Get Your Files Here !/5 - Risk evaluation/4. Risk evaluation.html17.51 KB
~Get Your Files Here !/6 - Risk control/24. Risk control option analysis.mp485.03 MB
~Get Your Files Here !/6 - Risk control/25. Implementation of risk control measures.mp458.6 MB
~Get Your Files Here !/6 - Risk control/26. Residual risk evaluation.mp418.63 MB
~Get Your Files Here !/6 - Risk control/27. Benefit-risk analysis.mp421.24 MB
~Get Your Files Here !/6 - Risk control/28. Risks arising from risk control measures.mp446.97 MB
~Get Your Files Here !/6 - Risk control/29. Completeness of risk control.mp439.79 MB
~Get Your Files Here !/6 - Risk control/5. Risk control.html18.37 KB
~Get Your Files Here !/7 - Evaluation of overall residual risk/30. Evaluation of overall residual risk.mp444.4 MB
~Get Your Files Here !/7 - Evaluation of overall residual risk/6. Evaluation of overall residual risk.html17.57 KB
~Get Your Files Here !/8 - Risk management review/31. Risk management review.mp446.54 MB
~Get Your Files Here !/8 - Risk management review/7. Risk management review.html17.56 KB
~Get Your Files Here !/9 - Production and post-production activities/32. General.mp435.12 MB
~Get Your Files Here !/9 - Production and post-production activities/33. Information collection.mp429.26 MB
~Get Your Files Here !/9 - Production and post-production activities/34. Information review.mp422.83 MB
~Get Your Files Here !/9 - Production and post-production activities/35. Actions.mp426.49 MB
~Get Your Files Here !/9 - Production and post-production activities/36. Thank you for your attention!.mp450.7 MB
~Get Your Files Here !/9 - Production and post-production activities/8. Production and post-production activities.html18.51 KB
~Get Your Files Here !/Bonus Resources.txt70 B

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