KEYcademy.com – 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.
- 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