[ WebToolTip.com ] Udemy - Becoming a Medical Device Safety Specialist (Hands-On)

• ~Get Your Files Here !/19 - Task 1 — Writing and Processing an ICSR/39. Writing an ICSR Validity, Procedure, Seriousness.mp4-37.34 MB
• ~Get Your Files Here !/14 - Vigilance and Incident Response/29. Vigilance What to Report, and the Reporting Clocks.mp4-34.53 MB
• ~Get Your Files Here !/24 - Case Studies When Devices Fail/54. The Insulin Pump Software Update.mp4-33.94 MB
• ~Get Your Files Here !/12 - The Device in Service Lifespan and Maintenance/27. The Device in Service Lifespan and Maintenance.mp4-33.64 MB
• ~Get Your Files Here !/5 - The Risk Management Process (ISO 14971)/13. What Can Go Wrong Hazard Families and the Tools to Find Them.mp4-33.47 MB
• ~Get Your Files Here !/6 - Weighing Risk Estimation, Evaluation, and Benefit/15. Evaluation and Benefit–Risk Drawing the Line.mp4-30.67 MB
• ~Get Your Files Here !/13 - Competent Hands Training and Assessment/28. Competent Hands Training and Assessment.mp4-30.02 MB
• ~Get Your Files Here !/18 - The Standing Report The PSUR/37. The PSUR Who Owes One, and What Goes In.mp4-29.35 MB
• ~Get Your Files Here !/15 - Did the Device Do It Causality Assessment/32. Three Formal Methods, and From Assessment to Action.mp4-28.32 MB
• ~Get Your Files Here !/14 - Vigilance and Incident Response/30. Investigation, CAPA and Closing the Loop.mp4-28.26 MB
• ~Get Your Files Here !/11 - Clinical Evaluation Building the Evidence/25. Clinical Evaluation A Living Document.mp4-28.25 MB
• ~Get Your Files Here !/2 - What a Device Is, and Why Its Safety Is Never Optional/6. Risk Is the Organizing Principle, and Safety Is Shared.mp4-28 MB
• ~Get Your Files Here !/24 - Case Studies When Devices Fail/57. The Defibrillator's Untested Edge Case.mp4-27.14 MB
• ~Get Your Files Here !/8 - The Quality System ISO 13485/19. ISO 13485 The Quality System.mp4-27.11 MB
• ~Get Your Files Here !/24 - Case Studies When Devices Fail/55. The Pacemaker Battery Defect.mp4-26.83 MB
• ~Get Your Files Here !/18 - The Standing Report The PSUR/38. The PSUR From Data to Decision.mp4-26.63 MB
• ~Get Your Files Here !/17 - Going Looking Post-Market Clinical Follow-up/36. How PMCF Is Done, and Closing the Loop.mp4-26.34 MB
• ~Get Your Files Here !/20 - Task 2 — Performing a Causality Assessment/42. Causality Assessment Gather, Weigh, Score.mp4-26.34 MB
• ~Get Your Files Here !/9 - Biocompatibility ISO 10993/22. Materials and Chemical Characterization.mp4-26.2 MB
• ~Get Your Files Here !/7 - Controlling Risk/16. The Hierarchy Design First, Warnings Last.mp4-26.05 MB
• ~Get Your Files Here !/9 - Biocompatibility ISO 10993/21. Biocompatibility ISO 10993.mp4-25.82 MB
• ~Get Your Files Here !/24 - Case Studies When Devices Fail/56. The MRI Calibration Error.mp4-25.4 MB
• ~Get Your Files Here !/10 - Materials of Animal Origin/24. Three Lines of Defense Sourcing, Processing, Traceability.mp4-25.23 MB
• ~Get Your Files Here !/24 - Case Studies When Devices Fail/58. The Threads That Recur.mp4-24.64 MB
• ~Get Your Files Here !/3 - The Regulatory Landscape/7. The Regulatory Landscape Six Authorities, One Logic.mp4-24.09 MB
• ~Get Your Files Here !/10 - Materials of Animal Origin/23. Materials of Animal Origin.mp4-24.08 MB
• ~Get Your Files Here !/16 - How Far Does It Reach Impact and Issue Assessment/34. Team, Scope, Data, and the Pattern in Practice.mp4-23.64 MB
• ~Get Your Files Here !/6 - Weighing Risk Estimation, Evaluation, and Benefit/14. Estimation Putting a Size on Risk.mp4-23.15 MB
• ~Get Your Files Here !/25 - Career Guide Building Your Résumé and Landing the Interview/59. Translate What You Already Have.mp4-22.66 MB
• ~Get Your Files Here !/11 - Clinical Evaluation Building the Evidence/26. Risk–Benefit and the Worked CER.mp4-22.53 MB
• ~Get Your Files Here !/17 - Going Looking Post-Market Clinical Follow-up/35. Post-Market Clinical Follow-up Why and When.mp4-22.5 MB
• ~Get Your Files Here !/25 - Career Guide Building Your Résumé and Landing the Interview/62. The Interview Technical Questions.mp4-22.45 MB
• ~Get Your Files Here !/15 - Did the Device Do It Causality Assessment/31. Did the Device Do It The Four Threads of Evidence.mp4-22.43 MB
• ~Get Your Files Here !/1 - Welcome Your Path into Device Safety/2. What a Device Safety Specialist Actually Does.mp4-22.26 MB
• ~Get Your Files Here !/22 - Task 4 — Conducting Risk Assessment and Management/48. Risk Assessment by Hand The Loop and the Template.mp4-22.12 MB
• ~Get Your Files Here !/21 - Task 3 — Preparing Aggregate Safety Reports/45. Aggregate Reports Scope, Denominator, Procedure.mp4-21.99 MB
• ~Get Your Files Here !/4 - Classifying Risk How Devices Are Sorted/11. Worked Example Classifying the SmartBand-Aid.mp4-21.58 MB
• ~Get Your Files Here !/2 - What a Device Is, and Why Its Safety Is Never Optional/5. Device or Drug The Definition That Draws the Line.mp4-21.22 MB
• ~Get Your Files Here !/8 - The Quality System ISO 13485/20. ISO 13485 in Practice.mp4-19.82 MB
• ~Get Your Files Here !/7 - Controlling Risk/18. Worked Example The Wearable Blood-Pressure Monitor.mp4-19.78 MB
• ~Get Your Files Here !/3 - The Regulatory Landscape/9. When Something Goes Wrong Reporting and CAPA.mp4-19.58 MB
• ~Get Your Files Here !/25 - Career Guide Building Your Résumé and Landing the Interview/60. The Résumé.mp4-19.32 MB
• ~Get Your Files Here !/7 - Controlling Risk/17. Proving It Works Verification, Validation and Residual Risk.mp4-19.13 MB
• ~Get Your Files Here !/16 - How Far Does It Reach Impact and Issue Assessment/33. Impact and Issue Assessment A Structured Loop.mp4-18.66 MB
• ~Get Your Files Here !/23 - Task 5 — Performing a Benefit–Risk Assessment/51. Benefit–Risk Characterize, Weigh, Conclude.mp4-18.54 MB
• ~Get Your Files Here !/1 - Welcome Your Path into Device Safety/4. Your Toolkit Templates, Quizzes and Free Interactive Tools.mp4-18.01 MB
• ~Get Your Files Here !/25 - Career Guide Building Your Résumé and Landing the Interview/61. Strengthen the Case with Training.mp4-17.88 MB
• ~Get Your Files Here !/4 - Classifying Risk How Devices Are Sorted/10. Classifying Risk Two Systems, One Logic, Four Questions.mp4-17.64 MB
• ~Get Your Files Here !/22 - Task 4 — Conducting Risk Assessment and Management/50. Your Turn Build a Risk Register.mp4-17.46 MB
• ~Get Your Files Here !/25 - Career Guide Building Your Résumé and Landing the Interview/63. The Interview Behavioral Questions.mp4-16.75 MB