Description
KEYcademy.com – On-demand Training
Roadmap to Market 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 and US.
With this training (Step 3) you will get a first insight in the regulatory landscape that surrounds Quality management Systems for Medical Devices. It covers mainly European and US requirements but gives a brief description of other International activities in the regulatory area.
There are several courses in this series, take them step by step to become more comfortable in your role as a Regulatory affairs professional.
Content
- What is a medical device and why is it different to other products
- How are medical devices classified
- Regulatory requirements on medical devices
- How to get a medical device to the market
- How does it impact daily tasks in a MD company
- Brief overview of ISO 13485
- Where can you find out more
Duration: 63 minutes
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