Roadmap to Market step 5 – Software as a Medical Device

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 5) you will get more insight in the general requirements for Medical Device Software.

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
Step 4 – Design and development
Step 5 – Medical Device Software (this course)
Step 6 – Post market Surveillance

Content, Step 5

• Introduction
• Embedded Software – SW in a Medical Device
• Standalone Software
• How to know if it is a medical device?
• Overview of requirements
• Risk management and classification
• Key considerations
• Summary

Duration: 29 minutes

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