Roadmap to Market Step 3 – Medical Device QMS Introduction
Overview of requirements for Medical Devices
Roadmap to Market is a training series 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:
Step 1 – EU
Step 2 – US
Step 3 – Medical device QMS Introduction (this course)
Step 4 – Design and development
Step 5 – Medical Device Software
Step 6 – Post market Surveillance
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
Course access
Access time: 90 days
#8015
€ 190