Roadmap to Market Step 2 – US and the FDA

Roadmap to Market Step 2 is a training in recognizing basic regulatory vocabulary and introduction to relationships between some regulatory terms & concepts that govern Medical Device manufacture within the 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:

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

Content

• Similarities and differences in definition, US vs EU?
• Introduction Regulatory process for Medical Devices in the US
• Risk classification and risk-based regulatory pathways
• Build in quality during development and document it in Design History File
• When FDA requires Post-Market Surveillance
• Introduction to useful resources on FDA website
• Tasks and exercises are described in Course material

Duration: 31 minutes

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