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FDA compliant medical device development and manufacturing --> [ DevCourseWeb ]

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Other > Training

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English

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3.26 GB

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d9a8f871660abcae73913489cf3f8b1501f4a2cb

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FreeCourseWeb :_trusted_uploader:

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09-09-2024 17:32

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File	Size
Get Bonus Downloads Here.url	182.00 B
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/1 - APPROPRIATE QUIZ TIME.html	92.00 B
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/1 - MP4-GCMI-SECTION-1-FOR-RESOURCE-SECTION.mp4	274.18 MB
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/1 - VIDEO SECTION 1 SLIDES 112 PROVIDE GOOD CARDS MEDICAL INTL COMPANY INFORMATION.html	1.53 kB
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/2 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf	264.17 kB
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/2 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf	207.69 kB
~Get Your Files Here !/1 - THIS COVERS LECTURE 1 VIDEO SLIDES 112 AND LECTURE 2 VIDEO SLIDES 1348/2 - VIDEO SECTION 2 SLIDES 1348 COVER DETAIL PROCESS OF DEVELOPING MEDICAL DEVICES.html	3.15 kB
~Get Your Files Here !/2 - VIDEO SECTION 3 SLIDES 4988 LISTS FDA OTHER WEBSITES HYPERLINKS WITH IDs/2 - APPROPRIATE TIME FOR A QUIZ.html	68.00 B
~Get Your Files Here !/2 - VIDEO SECTION 3 SLIDES 4988 LISTS FDA OTHER WEBSITES HYPERLINKS WITH IDs/3 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf	264.17 kB
~Get Your Files Here !/2 - VIDEO SECTION 3 SLIDES 4988 LISTS FDA OTHER WEBSITES HYPERLINKS WITH IDs/3 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf	207.69 kB
~Get Your Files Here !/2 - VIDEO SECTION 3 SLIDES 4988 LISTS FDA OTHER WEBSITES HYPERLINKS WITH IDs/3 - VIDEO SECTION 3 SLIDES 49 88 FDA REGULATORY WEBSITES H L INFO.html	1.26 kB
~Get Your Files Here !/3 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS USA DEVICE EXP AND FDA RECALL INFO/3 - APPROPRIATE QUIZ TIME.html	68.00 B
~Get Your Files Here !/3 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS USA DEVICE EXP AND FDA RECALL INFO/4 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-13-14-15.pdf	211.86 kB
~Get Your Files Here !/3 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS USA DEVICE EXP AND FDA RECALL INFO/4 - VIDEO SECTION 4 SLIDES 89 101 FOUNDERS DEVICE DEVT MFG EXPERIENCE.html	627.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/10 - ISO INFORMATION.html	60.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/11 - FDA QSMR ANNOUNCEMENT DETAILS.html	55.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/12 - FDA MEDICAL DEVICE DEVELOPMENT PROCESS MONITORING.html	59.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/13 - FDA MEDICAL DEVICE CLASSES.html	77.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/14 - DEVICE DEVELOPMENT KEY PROCESS RELATED INFO.html	58.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/15 - DEVELOPMENT PROCESS COMPLIANCE AND MONITORING RESPONSIBILITIES.html	77.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/16 - COMPANY QUALITY SYSTEM MANUAL.html	152.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/17 - FDA 483 OBSERVATIONS.html	28.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/19 - FDA FAQs.html	42.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/20 - MEDICAL DEVICE COMPANY ORGANIZATION.html	51.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/4 - WHAT IS BEST WAY TO GET CORRECT LATEST FDA GUIDELINES INFORMATION ONLINE.html	88.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/5 - CLICKABLE-PDF-GCMI-FDA-HYPERLINKS-1-16.pdf	264.17 kB
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/5 - CLICKABLE-PDF-GCMI-FDA-INTL-WEBSITES-A-G.pdf	207.69 kB
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/5 - IN THIS SECTION NARRATED VIDEO HOW TO DEVELOP MEDICAL DEVICE IS ADDED.mp4	2.95 GB
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/5 - SEARCHEABLE FDA WEBSITE.html	218.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/6 - FDA 510 K PREMARKET NOTIFICATION PMA APPROVAL.html	111.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/6 - FINAL-MP4-GCMI-VIDEO-PAGE-FOR-LECTURE-6.mp4	26.95 MB
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/6 - THIS QUIZ IS RELATED TO THE NARRATED 2 12 HRS MAIN COURSE VIDEO FROM LECTURE 5.mp4	8.10 MB
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/7 - CORRECT FDA WEBSITE.html	35.00 B
~Get Your Files Here !/4 - 2 12 HRS NARRATED VIDEO BY FOUNDER AND RESOURCES SECTION WCLICKABLE LINKS/9 - FDA QSR INFORMATION.html	30.00 B
~Get Your Files Here !/Bonus Resources.txt	386.00 B

Description

[ DevCourseWeb.com ] FDA compliant medical device development and manufacturing

If You Need More Stuff, kindly Visit and Support Us -->> 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

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We upload these learning materials for the people from all over the world, who have the talent and motivation to sharpen their skills/ knowledge but do not have the financial support to afford the materials. If you like this content and if you are truly in a position that you can actually buy the materials, then Please, we repeat, Please, Support Authors. They Deserve it! Because always remember, without "Them", you and we won't be here having this conversation. Think about it! Peace...