Roadmap to Market Step 1 – the EU

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

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