Roadmap to Market Step 1 – the EU

Introduction to medical device regulation

On demand training

Roadmap to Market Step 1 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.

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

Step 1 – EU (this course)
Step 2 – US
Step 3 – Medical device QMS Introduction
Step 4 – Design and development
Step 5 – Medical Device Software
Step 6 – Post market Surveillance

Content, Step 1

  • 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?
  • Tasks and exercises are described in Course material at the bottom

Duration: 35 minutes

#8013

 190.00

No. persons
Date & Time
IndustryMedical Device
LanguageEnglish
LevelBasic
LocationOn demand
RegionEU
YOUR INSTRUCTOR(S)​
Share
CUSTOMIZE IN-HOUSE TRAINING?

Search

Search

Customized In-House training

To tailor the course to your needs, we would like you to take these questions into account when contacting us.

  • What topics do you want to include in the training?
  • Experience and knowledge level in the group? Similar or varied?
  • How many participants do you want to take part in the training?
  • Are there any specific routines that need improvement?
  • Would you like a verification test after the training?
  • Extent of the training, and preferable timeframe?
  • Online or as a on-site course at your location?

Send an Inquiry

We take great care of your contact details. To learn more, read our Privacy Policy