Medical Device Regulations by Udemy
Learn about the medical device industry and how to bring new products to market 510K, PMA, De Novo, ISO13485 and beyond!
Course Highlights
- Learn how medical devices go from idea to product
- Understand the 510K and PMA submission process for medical devices
- FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE
- Risk management and quality in device development
- Learn how to research new devices and companies
- Understand medical device career paths and opportunities
Skills you will learn!
Curriculum
4 Topics
Introduction
Medical Device Industry
Researching Medical Device Companies
Medical Device Careers
6 Topics
MD100 Medical Devices Overview
MD110 Medical Devices Definitions
MD115 Medical Device Regulations
MD120 Medical Device Regulations History
MD130 FDA History
FDA Regulations
5 Topics
MD200 Path to Market
MD210 Device Classification
MD230 510K and PMA
MD232 Predicates
MD234 FDA Databases
5 Topics
MD300 Clinical Trials
MD310 Investigational Device Exemptions (IDEs)
MD330 IDE Submissions
MD340 IDE Records & Reporting
MD350 Researching Clinical Trials
14 Topics
MD400 Quality Systems
MD405 Risk Management
MD410 GXP
MD412 GLP
MD414 GCP
MD416 GMP
MD418 Supply Chain
MD420 Design Controls
MD430 Design Inputs
MD440 Design Outputs
MD450 Verification and Validation
MD460 Design Transfer
MD470 Design Changes
MD480 Documentation
8 Topics
MD500 Medical Device Submissions
MD510 FDA Interactions
MD520 510K Submissions
MD530 510K Content
MD540 510K Abbreviated
MD550 510K Special
MD580 PMA Submissions
MD590 Change Communication
4 Topics
MD600 Post Market Surveillance
MD610 MDR
MD620 Recalls
MD630 522 Postmarket
Medical Device Regulations
Related Medical Device Development Courses
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