Practical Regulatory Affairs 2020 – European Medical Devices

Practical Regulatory Affairs 2020 – European Medical Devices, available at $74.99, has an average rating of 4.27, with 31 lectures, 1 quizzes, based on 586 reviews, and has 1614 subscribers.

You will learn about Learn about the new EU Medical Device Regulations and how it will impact different medical devices. Understand how to obtain CE Marking under the Medical Device Regulations. Complete real-world examples and exercises to apply the Medical Device Regulations to mock medical devices. This course is ideal for individuals who are Junior Regulatory Affairs professionals or Engineers with medical device experience or Physicians/Professors with device ideas or Medical device project team members It is particularly useful for Junior Regulatory Affairs professionals or Engineers with medical device experience or Physicians/Professors with device ideas or Medical device project team members.

Enroll now: Practical Regulatory Affairs 2020 – European Medical Devices

Summary

Title: Practical Regulatory Affairs 2020 – European Medical Devices

Price: $74.99

Average Rating: 4.27

Number of Lectures: 31

Number of Quizzes: 1

Number of Published Lectures: 31

Number of Published Quizzes: 1

Number of Curriculum Items: 33

Number of Published Curriculum Objects: 33

Original Price: €34.99

Quality Status: approved

Status: Live

What You Will Learn

Learn about the new EU Medical Device Regulations and how it will impact different medical devices.
Understand how to obtain CE Marking under the Medical Device Regulations.
Complete real-world examples and exercises to apply the Medical Device Regulations to mock medical devices.

Who Should Attend

Junior Regulatory Affairs professionals
Engineers with medical device experience
Physicians/Professors with device ideas
Medical device project team members

Target Audiences

Junior Regulatory Affairs professionals
Engineers with medical device experience
Physicians/Professors with device ideas
Medical device project team members

The EU Medical Device Regulations (MDR 2017/745) represents the biggest change to medical device legislation in Europe for over 20 years. The MDR affects all medical device manufacturers (and others!) wanting to sell devices in the EU. This course focuses on the practical application of the MDR, using real-world examples and exercises to help you understand not only what the Regulations mean, but what we need to do to comply with them.

Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to transition to the MDR.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction and Scope

Lecture 2: Instructor Tips

Chapter 2: Directives to Regulations

Lecture 1: MDD, IVDD and AIMDD

Lecture 2: Change is Coming

Lecture 3: Medical Device Regulations (EU MDR 2017/745)

Lecture 4: Key changes in the MDR

Lecture 5: The MDR Enforcers

Chapter 3: EU Regulatory Pathway

Lecture 1: MDR Regulatory Pathway Overview

Lecture 2: Medical Device Assessment

Lecture 3: Device Classification Basics

Lecture 4: Device Classification Annex VIII

Lecture 5: Practice Exercise: Device Classfication

Lecture 6: Walk-through: Device Classification

Lecture 7: Conformity Assessment Route

Chapter 4: EU Regulatory Submissions – Quality Management Systems

Lecture 1: Annex IX Conformity Assessment Route

Lecture 2: Quality Management Systems (QMS)

Lecture 3: Harmonized Standards and Common Specifications

Chapter 5: EU Regulatory Submissions – Technical Documentation

Lecture 1: Technical Documentation Overview

Lecture 2: Device Description

Lecture 3: Device Labeling and UDI

Lecture 4: Device Design and Manufacturing

Lecture 5: General Safety and Performance Requirements (GSPRs)

Lecture 6: Benefit Risk Analysis

Lecture 7: Product Verification and Validation

Lecture 8: Post-Market Surveillance (PMS) Technical Documentation

Lecture 9: Technical Documentation Summary

Chapter 6: EU Regulatory Pathway – Final Steps

Lecture 1: Declaration of Conformity

Lecture 2: Notified Bodies and CE Marking Procedure

Lecture 3: EUDAMED

Lecture 4: MDR Timelines and Transitions

Chapter 7: Final Tools

Lecture 1: Final Tools

Instructors

Pubudi Silva
Instructor

Rating Distribution

1 stars: 2 votes
2 stars: 14 votes
3 stars: 62 votes
4 stars: 257 votes
5 stars: 251 votes

Frequently Asked Questions

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You can view and review the lecture materials indefinitely, like an on-demand channel.

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