Roadmap to Market - Step 1, the EU

Roadmap to Market - Step 1, the EU

Basic Level | English | Medical Device | 35 minutes

Corresponds to ½ day of teacher-directed learning

Description

Roadmap to Market is a training in recognizing basic regulatory vocabulary and introduction to relationships between some regulatory terms & concepts that govern Medical Device manufacture within the EU and US.

There are several courses in this series, take them step by step to become more comfortable in your role as a Regulatory affairs professional.

  1. 1.      Step 1 Roadmap to Market - EU (this course)
  2. 2.      Step 2 Roadmap to Market - US
  3. 3.      Step 3 Roadmap to market - Medical device QMS Introduction
  4. 4.      Step 4 Roadmap to market - Design and development
  5. 5.      Step 5 Roadmap to market - Software as a Medical device
  6. 6.      Step 6 Roadmap to market - Post market Surveillance

Content

  • What is a Medical Device?
  • What is the Intended Purpose and why is it relevant for determining the risk class of a device?
  • What are Conformity Assessment Procedures?
  • What is a Clinical Evaluation and what does Clinical Benefit mean?
  • What is a Quality Management System and why do we need it?
  • What is the Technical Documentation?
  • What are critical Post-Market activities?

Course modules

0. Introduction

Here I present myself, the purpose of the course, the goal we aim to achieve and the contents of the course.

Duration: 3 minutes (Total duration of the course: 35 minutes)

1. Exercise booklet - Roadmap to market EU

Exercise booklet - Roadmap to market EU

Trainer: Faisal Kamal
Duration: 1 minute (Total duration of the course: 35 minutes)

2. What is a Medical Device?

Medical Device definition, Qualification, Classification, Conformity Assessment Procedure

Trainer: Faisal Kamal
Duration: 8 minutes (Total duration of the course: 35 minutes)

3. Purpose and Benefit go hand in hand

Introduction to Clinical Evaluation, Clinical Benefit, Risks, Intended Purpose definition

Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 35 minutes)

4. Quality is KeyTry it!

Introduction to Quality Management System (QMS) requirements (Article 10)

Trainer: Faisal Kamal
Duration: 4 minutes (Total duration of the course: 35 minutes)

5. Realizing the idea requires planning

Introduction to General Safety and Performance Requirements (Annex I), General obligations and requirements, Introduction to Risk Management System requirements (Annex I)

Trainer: Faisal Kamal
Duration: 5 minutes (Total duration of the course: 35 minutes)

6. Technical File

The Technical Documentation - what is it?

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)

7. The product is out, but the work continues

Post-market Surveillance & Post-Market Clinical Follow-up

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)

8. Staying current is critical

State of the art and standards

Trainer: Faisal Kamal
Duration: 2 minutes (Total duration of the course: 35 minutes)

9. Summary

Summary of all modules

Trainer: Faisal Kamal
Duration: 3 minutes (Total duration of the course: 35 minutes)

Course material

If you want to access the additional course material for this course, you need to sign in and have access to this course.

Notes

If you want to save your notes for this course, you first need to purchase it and be signed in.


Training organisation

The course results in a diploma that shows that you have the skills required.


All prices shown exclude VAT.


Well done!

You have completed the Roadmap to Market - Step 1, the EU course, and you can now get your diploma.

Back to the course Get your diploma

The trailer is now over

Before you can start the Roadmap to Market - Step 1, the EU course, you first have to purchase it.

Back to the course
Roadmap to Market - Step 1, the EU 920 1 1950.0 Add to basket

Contact