FDA compliant medical device development and manufacturing
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
Description
As a Founder and CEO of Good Cards Medical International,
I would like to welcome you to this course & learn about
'OVERVIEW of how to develop and manufacture medical devices in compliance with FDA & International regulations'.
I do have 30+ years of hands on and managment experience with medical device industry in USA with fortune 500 and startup companies
with device development involvement and A - Z manufacturing operations management.
My passion and vision
is to share this knowledge and experience
for the success of world wide
medical device current entrepreneurs,
established device company executives plus management and staff,
future entrepreneurs
from medical and engineering students from all desciplines and other educated beneficiaries interested in a
very satisfying career
in medical device industry.
Medical device development and manufacturing process is
extremely detailed with several regulatory
requirements,
but once understood it becomes easy to follow the regulations.
This industry does require proper qualified support organization.
In addition to the current entrepreneurs, there are multiple opportunities for educated personnel to be part of this wonderful world wide medical device industry.
All educated personnel have a place in this industry.
All you need is a strong desire.
This course definitely gives an
OVERVIEW ONLY from A - Z of what is involved. Please remember this is an OVERVIEW with several pointers towards required regulatory guidelines.
This course will & should help interested beneficiaries to make proper decisions about their career and career plans.
This course covers process information about
how to develop medical devices from concept all the way to commercial shipment, including regulatory guidelines and requirements
.
It does include Medical Instrumentation and sterilized disposable devices.
Given below is required key structure & development processes.
Company's required
organizational structure
for device development
Company
Quality Manual
which includes all regulatory requirements
Device design
& design reviews
Device design & manufacturing process
development and verifications / validations
Final
regulatory compliant
manfucaturing production
Manufacturing
Quality Controls
Device design and manfucaturing
documentation controls
& requirements
Supply chain
qualifications and monitoring
Regulated
facilities requirements
This course will benefit
Entrepreneurs
who should know what is required to develop and manufacture a medical device so they can confidentially know details to determine the level of funding required for a successful company.
Medical students
who have device ideas and aspire to be medical device Entrepreneurs & should know upfront what is involved
All desciplines of engineering students
with a strong desire for a career in medical device industry
College students with all desciplines
with a strong desire for a career in medical device industry
Device industry management personnel & executives
to possess proper information so they can manage departments properly for company's success and also help them hire qualified personnel
Doctors, Nurses and hospital staff to understand device development and manufacturing overview information to develop an appreciation for the devices
Who this course is for
MEDICAL DEVICE INDUSTRY FORTUNE 500 AND STARTUP COMPANIES AND THEIR R & D ENGINEERING, MANUFACTURING ENGINEERING & OPERATIONS & QUALITY ENGINEERING AND DEPARTMENT EMPLOYEES, MEDICAL DEVICE DEVELOPMENT ENTREPRENUERS, MEDICAL UNIVERSITIES AND THEIR STAFF AND STUDENTS, ENGINEERING UNIVERSITIES - COLLEGES STAFF & BIOMEDICAL ENGINEERING STUDENTS & OTHER ENGINEERING DESCIPLINES
DOCTORS, NURSES, HOSPITAL STAFF, HEALTHCARE INDUSTRY PERSONNEL WITH DESIRE TO UNDERSTAND HOW MEDICAL DEVICES ARE DEVELOPMED AND MANUFACTURED IN COMPLIANCE WITH THE FDA & INT'L REGULATIONS INCLUDING SAFETY & EFFICACY
ESTABLISHED & STARTUP MEDICAL DEVICE COMPANY'S MANAGEMENT & EXECUTIVE STAFF
ESTABLISHED & STARTUP MEDICAL DEVICE COMPANY STAFF IN ALL DEPARTMENTS, INCLUDING ASSEMBLY OPERATORS & JANITORS. PERSONNEL WHO NEED HELP TO BE TRAINEED BY DEPARTMENT MANAGEMENT IN CONJUNCTION WITH QUALITY DEPARTMENT
MEDICAL DEVICE COMPANY'S CONSULTANTS AND SUPPLY CHAIN PERSONNEL WITH ALL ABOVE DESCIPLINES
MEDICAL DEVICE INDUSTRY VENTURE CAPITALISTS & INVESTORS WITH A NEED TO UNDERSTAND MEDICAL DEVICE DEVELOPMENT PROCESS OVERVIEW AND REQUIRED INFRASTRUCTURE
ALSO, DESIGN, SUSTAINING, MANUFACTURING , QUALITY ENGINEERS AND OTHER DEPARTMENTAL STAFF FROM OTHER INDUSTRIES WHO HAVE DESIRE TO WORK IN MEDICAL DEVICE INDUTRY.
Homepage:
https://www.udemy.com/course/fda-compliant-medical-device-development-and-manufacturing/Screenshots
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Cantinho Satkeys
