What you'll learn

Different definitions of Medical Devices and In-Vitro Diagnostics IVDs
Classifications of Medical Devices and In-Vitro Diagnostics IVDs
Regulations of Medical Devices and IVDs
Quality Management System

Requirements

This course is for beginners in regulatory affairs of medical devices and who wish to know the basics behind the medical devices
Scientific background is required but not mandatory

Description

This course offers a comprehensive introduction to the regulatory landscape for medical devices. It covers essential topics such as device classification, regulatory frameworks, clinical evaluation, quality management systems, and post-market surveillance. Participants will gain practical insights into the key regulatory

Requirements

and processes necessary for compliance in major global markets.Who Should Attend?This course is ideal for:- New professionals in the medical device industry.- Regulatory affairs professionals transitioning from other industries.- Quality assurance and compliance personnel.- R&D engineers and project managers.- Healthcare professionals interested in regulatory aspects of medical devices.- Anyone seeking a foundational understanding of medical device regulations.Learning Outcomes:By the end of this course, participants will be able to:1. Understand the regulatory classification of medical devices.2. Navigate key global regulatory frameworks, including EU MDR and FDA regulations.3. Develop and maintain technical documentation and quality management systems.4. Prepare for regulatory submissions and market access.Outlines:1. Introduction to Medical Devices- Definition and examples- Device vs. pharmaceuticals2. Regulatory Frameworks-

Overview

of global regulations- Key regulatory authorities3. Device Classification- Classification criteria and examples- Risk-based classification4. Conformity Assessment and CE Marking- Notified Bodies and their roles- Steps to obtain CE marking5. Technical Documentation- Essential components- Preparing a technical file6. Quality Management Systems (QMS)- ISO 13485

Overview

- QMS implementation7. Regulatory Submissions and Approvals- Submission processes for major markets- Interactions with regulatory authorities

Overview

Section 1: Introduction
Lecture 1 WHO Definition of Medical Devices
Lecture 2 WHO Definition of In-Vitro Diagnostics IVDs
Lecture 3 FDA Definition
Lecture 4 EU definitions
Lecture 5 Intended purpose & Notified Bodies
Lecture 6 Is my product a medical device?
Section 2: Classifications of Medical Devices
Lecture 7 Importance of Classification & WHO
Lecture 8 EU classification 1
Lecture 9 EU Classification 2
Lecture 10 Examples
Lecture 11 FDA Classification
Lecture 12 FDA Class II submissions
Lecture 13 Classification in KSA, UAE, and Egypt
Section 3: Regulatory

Requirements

Lecture 14 WHO Regulations
Lecture 15 FDA Regulations
Lecture 16 EMA regulations
Lecture 17 Saudi FDA Regulations
Lecture 18 UAE Regulations
Lecture 19 Egypt Regulations
Section 4: In-Vitro Diagnostics (IVDs)
Lecture 20 In-Vitro Diagnostics (IVDs)
Section 5: Unique Device Identifier
Lecture 21 Unique Device Identifier
Section 6: Quality Management System
Lecture 22 Quality Management System
Fresh graduates from scientific field,Regulatory affairs specialists,medical devices engineers


Homepage:

https://www.udemy.com/course/fundamentals-of-medical-devices/