Medical Device Regulation (MDR): Intro for Device Designers

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Medical Device Regulation (MDR): Intro for Device Designers
at
UDEMY
Overview

An introduction to the EU's Medical Device Regulation (MDR) for those involved in developing medical devices

Duration	1 hour
Total fee	₹649
Mode of learning	Online
Credential	Certificate

Medical Device Regulation (MDR): Intro for Device Designers

Table of content

Overview
Highlights
Course Details
Curriculum
Faculty

Medical Device Regulation (MDR): Intro for Device Designers
at
UDEMY
Highlights

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Medical Device Regulation (MDR): Intro for Device Designers
at
UDEMY
Course details

Skills you will learn

Marketing Research Sales Marketing Risk Management Technical Documentation ISO

Who should do this course?

For Engineers and designers looking to learn more about the EU's Medical Device Regulation (MDR)

What are the course deliverables?

The overall requirements and structure of the Medical Device Regulation (MDR)
Understanding the structure and content of the related international standard on Medical Device Software EN 62304
Understanding the structure and content of the related international standard on the Application of Risk Management to Medical Devices ISO 14971
What are the general safety and performance requirements set out in the MDR

More about this course

Welcome to this short video series introducing the European Union's Medical Device Regulation (MDR)
We run through a lot of the topics covered in the MDR starting at what specifically count as medical devices, what rules govern the marketing claims which can be made about them and how development for the MDR relates to international harmonised standards
In this series, we focus more on aspects of the MDR relevant to design and development of devices in preparation for sale rather than, distribution, post market requirements, or the requirements placed on notified bodies which are also covered in the MDR

Medical Device Regulation (MDR): Intro for Device Designers
at
UDEMY
Curriculum

Course Overview

Course Overview

Overview and General Requirements

Introduction, Medical devices definition, Claims & Standards

General Obligations on Manufacturers

Traceability Classification and Notified Bodies

Safety and Performance Requirements, Clinical Evaluation & Technical Documentation

Clinical Evaluations and Clinical Investigations

General Safety and Performance Requirements

Technical Documentation

Focus on

Software in the MDR & an Introduction to IEC 62304

Risk Management in the MDR & an Introduction to ISO 14971

Medical Device Regulation (MDR): Intro for Device Designers
at
UDEMY
Faculty details

James Holmes

James is an electronics and software engineer with 12 years of experience developing technology solutions for applications ranging from autonomous robotics to medical devices. He has a PhD in the field of power electronics and he has extensive experience of medical device development from drug delivery devices to diagnostics products.