KEYcademy.com – On-demand Training
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.
- 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 at the bottom
Duration: 31 minutes