European Medical Device Regulatory Basics

European Medical Device Regulatory Basics, available at $79.99, has an average rating of 4.4, with 7 lectures, based on 33 reviews, and has 63 subscribers.

You will learn about Be able to tell differences between EU and US approach to medical device regulation Understand how to begin the regulatory process in EU for your device Have a basis for pursuing further information on EU medical device regulation This course is ideal for individuals who are Engineers with medical device experience or Medical device project team members or Students interested in pursuing device careers or Physicians/Professors with device ideas It is particularly useful for Engineers with medical device experience or Medical device project team members or Students interested in pursuing device careers or Physicians/Professors with device ideas.

Enroll now: European Medical Device Regulatory Basics

Summary

Title: European Medical Device Regulatory Basics

Price: $79.99

Average Rating: 4.4

Number of Lectures: 7

Number of Published Lectures: 7

Number of Curriculum Items: 7

Number of Published Curriculum Objects: 7

Original Price: $79.99

Quality Status: approved

Status: Live

What You Will Learn

Be able to tell differences between EU and US approach to medical device regulation
Understand how to begin the regulatory process in EU for your device
Have a basis for pursuing further information on EU medical device regulation

Who Should Attend

Engineers with medical device experience
Medical device project team members
Students interested in pursuing device careers
Physicians/Professors with device ideas

Target Audiences

Engineers with medical device experience
Medical device project team members
Students interested in pursuing device careers
Physicians/Professors with device ideas

This is a bare basics overview of how medical devices are regulated in the European Union (EU). You will learn how the EU government creates laws and regulations that control medical device approvals there.

The course covers three main areas:

1) Governmental structure of the EU

2) The EU Directives that deal with medical devices

3) The structure of a Tech File/Design Dossier which is submitted for a device.

The course is intended for those with no knowledge of device regulation in the EU. After taking this course, you will understand where to go next with your EU device project, from a regulatory standpoint, and you will know how to gain additional learning for your desired device approval.

Course Curriculum

Chapter 1: European Medical Device Regulatory Basics

Lecture 1: Introduction

Lecture 2: EU Regulatory Introduction

Lecture 3: EU Government Structure and Legislation Process

Lecture 4: Medical Device Directives

Lecture 5: Tech File and Design Dossier Basics

Lecture 6: Introduction to MDR and IVDR

Lecture 7: Similarities and Differences Between New Approach and MDR/IVDR

Instructors

Josh Simon
Medical Device Development Professional

Rating Distribution

1 stars: 1 votes
2 stars: 1 votes
3 stars: 7 votes
4 stars: 16 votes
5 stars: 8 votes

Frequently Asked Questions

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