Udemy - FDA compliant medical device development and manufacturing

  • CategoryOther
  • TypeTutorials
  • LanguageEnglish
  • Total size3.3 GB
  • Uploaded Byfreecoursewb
  • Downloads4
  • Last checkedSep. 20th '24
  • Date uploadedSep. 19th '24
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Infohash : D9A8F871660ABCAE73913489CF3F8B1501F4A2CB

FDA compliant medical device development and manufacturing

https://DevCourseWeb.com

Published 8/2024
Duration: 2h46m | Video: .MP4, 1920x1080 30 fps | Audio: AAC, 44.1 kHz, 2ch | Size: 3.25 GB
Genre: eLearning | Language: English

Learn OVERVIEW of how to develop and manufacture a medical device in compliance with FDA and International regulations

What you'll learn
OVERVIEW OF 'HOW TO DEVELOP (FROM CONCEPT ALL THE WAY TO COMMERCIAL SHIPMENT) MEDICAL DEVICES AND MANUFATURE IN COMPLIANCE WITH FDA & INTERNATIONAL REGULATIONS'
UNDERSTADING OF FDA'S ONLINE ALL AVAILABLE GUIDELINE PUBLICATIONS & UPDATES RELATED TO MEDICAL DEVICE REGULATORY COMPLIANCE AND APPROVALS AND RELATED TOPICS
DEVICE DESIGN VERIFICATION & VALIDATIONS, DESIGN PROCESS, MFG. PROCESS V & V, QUALITY, DOCUMENTATION, SUPPLY CHAIN CONTROLS & OTHER REGULATORY REQUIREMENTS
HOW TO UNDERSTAND & MANEUVER USA FDA WEBSITE & SEVERAL HYPERLINKS RELATED TO DEVICE DEVELOPMENT DESIGN, MFG. PROCESS & QUALITY & OTHER REGULATION REQUIREMENTS
1. FDA DEVICE CLASSIFICATIONS CLASS I, CLASS II AND CLASS III .......... 2. FDA AUDITS AND WHAT ARE 483 NOTIFICATIONS ......... 3. FDA RECALL CIRCUMSTANCES
FINALLY, REQUIRED ORGANIZATIONAL STRUCTURE AND PERSONNEL REGULATORY TRAINING REQUIRED TO RUN A MEDICAL DEVICE COMPANY.

Requirements
WELL EDUCATED PERSONNEL WITH COLLEGE DEGREES OR IN-PROCESS DEGREES AND HIGH SCHOOL EDUCATION WITH DESIRE TO WORK IN MEDICAL INDUSTRY
DESIRE FOR A CAREER IN MEDICAL DEVICE DEVELOPMENT & MANUFACTURING OPERATIONS RELATED CAREER
DESIRE FOR A MEDICAL DEVICE INDUSTRY CAREER & EDUCATION IN DEVICE DESIGN, MANUFACTURING ENGINEERING, MFG. OPERATIONS, QUALITY & REGULATORY & OTHER RELATED DEPARTMENTS
LEARN ABOUT REGULATORY REQUIREMENTS IN 1) DESIGNING A MEDICAL DEVICE 2) VERIFICATION & VALIDATION OF A MEDICAL DEVICE 3) DEVICE MANUFACTURING PROCESS DEVELOPMENT AND VERIFICATION & VALIDATION 4) DESIGN & MFG. DOCUMENTATION AND DOCUMENTATION CONTROLS 5) DEVICE QUALITY CONTROLS 6) PURCHASING & SUPPLY CHAIN QUALIFICATION AND CONTROLS 7) AND OTHER REGULATORY GUIDELINES ALL THE WAY TO COMMERCIAL SHIPMENT AND BEYOND 8) AND FINALLY MEDICAL DEVICE DEVELOPMENT AND MANUFACTURING FACILITY INCLUDING CLEAN ROOM GUIDELINES.
IN ADDITION, LEARN ABOUT OVERVIEW REQUIREMENTS OF A MEDICAL DEVICE STARTUP COMPANY

Files:

[ DevCourseWeb.com ] Udemy - FDA compliant medical device development and manufacturing
  • Get Bonus Downloads Here.url (0.2 KB)
    • ~Get Your Files Here ! 1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348
    • 1 - APPROPRIATE QUIZ TIME.html (0.1 KB)
    • 1 - MP4-GCMI-SECTION-1-FOR-RESOURCE-SECTION.mp4 (274.2 MB)
    • 1 - VIDEO SECTION 1 SLIDES 112 PROVIDE GOOD CARDS MEDICAL INTL COMPANY INFORMATION.html (1.5 KB)
    • 2 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf (264.2 KB)
    • 2 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf (207.7 KB)
    • 2 - VIDEO SECTION 2 SLIDES 1348 COVER DETAIL PROCESS OF DEVELOPING MEDICAL DEVICES.html (3.1 KB)
    2 - VIDEO SECTION 3 SLIDES 4988 LISTS FDA OTHER WEBSITES HYPERLINKS WITH IDs
    • 2 - APPROPRIATE TIME FOR A QUIZ.html (0.1 KB)
    • 3 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf (264.2 KB)
    • 3 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf (207.7 KB)
    • 3 - VIDEO SECTION 3 SLIDES 49 88 FDA REGULATORY WEBSITES H L INFO.html (1.3 KB)
    3 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS USA DEVICE EXP AND FDA RECALL INFO
    • 3 - APPROPRIATE QUIZ TIME.html (0.1 KB)
    • 4 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-13-14-15.pdf (211.9 KB)
    • 4 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS DEVICE DEVT MFG EXPERIENCE.html (0.6 KB)
    4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS
    • 10 - ISO INFORMATION.html (0.1 KB)
    • 11 - FDA QSMR ANNOUNCEMENT DETAILS.html (0.1 KB)
    • 12 - FDA MEDICAL DEVICE DEVELOPMENT PROCESS MONITORING.html (0.1 KB)
    • 13 - FDA MEDICAL DEVICE CLASSES.html (0.1 KB)
    • 14 - DEVICE DEVELOPMENT KEY PROCESS RELATED INFO.html (0.1 KB)
    • 15 - DEVELOPMENT PROCESS COMPLIANCE AND MONITORING RESPONSIBILITIES.html (0.1 KB)
    • 16 - COMPANY QUALITY SYSTEM MANUAL.html (0.1 KB)
    • 17 - FDA 483 OBSERVATIONS.html (0.0 KB)
    • 19 - FDA FAQs.html (0.0 KB)
    • 20 - MEDICAL DEVICE COMPANY ORGANIZATION.html (0.0 KB)
    • 4 - WHAT IS BEST WAY TO GET CORRECT LATEST FDA GUIDELINES INFORMATION ONLINE.html (0.1 KB)
    • 5 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf (264.2 KB)
    • 5 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf (207.7 KB)
    • 5 - IN THIS SECTION NARRATED VIDEO HOW TO DEVELOP MEDICAL DEVICE IS ADDED.mp4 (3.0 GB)
    • 5 - SEARCHEABLE FDA WEBSITE.html (0.2 KB)
    • 6 - FDA 510 K PREMARKET NOTIFICATION PMA APPROVAL.html (0.1 KB)
    • 6 - FINAL-MP4-GCMI-VIDEO-PAGE-FOR-LECTURE-6.mp4 (27.0 MB)
    • 6 - THIS QUIZ IS RELATED TO THE NARRATED 2 12 HRS MAIN COURSE VIDEO FROM LECTURE 5.mp4 (8.1 MB)
    • 7 - CORRECT FDA WEBSITE.html (0.0 KB)
    • 9 - FDA QSR INFORMATION.html (0.0 KB)
    • Bonus Resources.txt (0.4 KB)

Code:

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