Master Medical Device Development & FDA Regulatory Affairs

Name: Master Medical Device Development & FDA Regulatory Affairs
Rating: 4.7 (37 reviews)

Learn Medical Device Regulatory Affairs, Classification, Intended Use, FDA Databases, Premarket Pathways & UDI Labels

Created byRobert Ryan

Last updated 12/2025

English

What you'll learn

Master key parts of the U.S. medical device regulatory framework, from concept to — market.
Learn how to classify your device, write the intended use and indications for use statements and choose the right premarket pathway .
Gain practical how-to knowledge to enable you plan and execute performance and usability testing that meets FDA expectations as part of eSTAR submissions
Learn the key requirements for medical device labelling, labels, and UDI requirements to stay fully compliant.

Course content

4 sections • 37 lectures • 14h 55m total length

Course Introduction13:33
Explore the structure of medical device development and FDA regulatory affairs, including risk and safety, the device lifecycle, quality management, pre-market pathways, and practical guidance for compliant design and submission.
Section Introduction0:33
Medical Devices, Safety and Risk15:57
Quiz: Safety and Risk
ISO 14971 Risk Management and the V-Model Overview16:31
Explore ISO 14971 risk management and the V-model, detailing how to identify, mitigate, and verify risks in medical devices, using a clinical thermometer example to illustrate safety evidence.
Quiz: ISO 14971 Risk Management and the V-Model Overview
The Medical Device Lifecycle16:46
Quiz: Medical Device Lifecycle
ISO 13485 Quality Management System Overview23:59
Quiz: ISO 13485 QMS
Case Study: The Therac-25 Failure23:08
Quiz: Therac-25

Section Introduction1:19
Trace the FDA history, device failure case studies, and US regulatory structure; explore pre-market forms, medical device definitions, intended use and indications for use, and FDA guidances and consensus standards.
FDA Regulations History21:49
Quiz: FDA History
US Regulatory Structure43:03
Quiz: US Regulatory Structure
Medical Device Definition per ISO 1497131:04
Explore the ISO 14971 definition. Learn how software, in vitro use reagents, and implants fall under medical devices, and how they differ from drugs.
Quiz: General Medical Device Definition
Intended Use24:11
Quiz: Intended Use
Medical Device Definition per FDA21:39
Quiz: FDA Medical Device Definition

Section Introduction1:09
Medical Device Classification & Pathways Overview53:04
Learn how the FDA classifies devices into class I, II, and III by risk, determines regulatory controls and pathways (510(k), PMA, de novo, HDE), and uses product codes.
Quiz: Medical Device Classification
FDA Product Codes39:14
Quiz: FDA Product Codes
Informing Product Development15:50
Learn how regulatory affairs inform product development by using FDA databases and product codes to guide design team with special controls, guidance documents, and consensus standards that shape risk management.
Quiz: Informing Product Development
Establishment and Device Registration8:08
Quiz: Device & Establishment Registration
Accessory and Components39:27
Quiz: Accessory vs Component
Sterile Devices15:14
Quiz: Sterile Devices
Configuration Management23:03
Quiz: Configuration Management
Example: Electrosurgical Generator31:15
Substantial Equivalence43:02
Quiz: Substantial Equivalence
Performance Bench Testing40:35
Quiz: Performance Testing
Usability Testing17:49
Quiz: Usability Testing
Clinical Evaluation Part I41:26
Plan, collect, and analyze clinical data for medical devices to verify safety and performance using clinical investigations, literature, adverse event data, and risk management for 510(k) and PMA.
Quiz: Clinical Evaluation Part I
Clinical Evaluation Part II37:21
Quiz: Clinical Evaluation Part II
Clinical Evaluation Part III19:43
Explore when clinical investigations occur in medical device development, from early production builds to regulatory submission, and outline preclinical, pilot, pivotal, and post-market studies with risk management and design controls.
Quiz: Clinical Evaluation Part III

Section Introduction2:29
Label, Labeling and Markings18:01
Quiz: Label, Labeling and Markings
Accompanying Information29:27
Explore labeling and accompanying information for medical devices, detailing intended use, indications, contraindications, instructions for use, safety symbols, and technical description per ISO 20417 and ISO 15223.
Quiz: Accompanying Information
Medical Device Symbols41:24
Quiz: Medical Device Symbols
Information For Safety14:46
Quiz: Information for Safety
Labelling Regulations Part I32:20
Quiz: Labeling Regulations
Labeling Regulations Part II22:45
Examine false or misleading statements under section 801.6, and apply prominence of labeling, symbol usage, date formats, and language considerations for FDA-compliant device labeling.
Quiz: Labeling Regulations II
Unique Device Identifier33:08
Quiz: UDI
How to get a UDI ?21:26

Requirements

While prior experience in medical devices is beneficial, the course is structured to provide foundational knowledge and advanced insights. Both beginners and experienced professionals will benefit from the material.

Description

This comprehensive course provides a clear, structured, and practical education on medical device development and U.S. medical device regulations, giving you the tools to navigate medical device development and FDA regulatory affairs with confidence, avoid costly development mistakes, and bring your device to market faster.

You will learn how to understand and apply the U.S. regulatory framework from classification and premarket pathways to labelling, UDI requirements, and key parts of the Code of Federal Regulations (CFR).You’ll gain the knowledge and strategic insight to take control of your development and regulatory processes.

Throughout the course, you’ll access real-world examples and practical explanations designed to make the complex world of medical device development look simple, actionable, and directly applicable to your product. You’ll also get a peek behind the curtain at proven documentation strategies to help make your FDA submissions clear, organized, and far less stressful. This course is designed for working professionals in the medical device industry, including regulatory affairs associates, quality managers, project managers, design engineers, software developers tc.

You’ll master essential topics such as: Medical device classification, intended use, indications for use, premarket pathways, FDA product codes, substantial equivalence, and eSTAR submissions. Gain insight into how to determine what performance testing, usability testing, and clinical evaluation will be needed as part of your product development to ensure regulatory clearance or approval. Learn the regulatory requirements around label, labels, and UDI requirements.

The course is structured to be completed in about 5 days, making it accessible and efficient for busy professionals. By the end of this course, you will confidently navigate the U.S. medical device regulatory landscape, knowing exactly how to position your device for fast, smooth market release. Eliminate dependency on external consultants, and instead build the expertise in-house.

Start your journey today to become a medical device development and regulatory expert — and bring your innovation to market faster than ever.

Who this course is for:

Professionals who work in the medical device industry including regulatory affairs associates, quality managers, project managers, design engineers, software/firmware developers or data scientists who wish to learn more about medical device regulatory affairs to aid in product development.

Master Medical Device Development & FDA Regulatory Affairs

What you'll learn

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Course content

Medical Device Development Overview7 lectures • 1hr 50min

US Regulatory Affairs Introduction6 lectures • 2hr 23min

FDA Premarket Pathways15 lectures • 7hr 6min

Labeling, Labels and the UDI9 lectures • 3hr 36min

Requirements

Description

Who this course is for: