Udemy - FDA compliant medical device development and manufacturing torrent

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