Roadmap to Market Step 4 – Design and development

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 4) you will get more insight in the requirements for controlling the development phase of a medical device. For low risk devices, focus are often mainly on that they are manufactured properly but as soon as they have a little bit higher risk to patient safety or include a Software, any company putting such a device on the market must control the development process as well. This training will give you a high level understanding of these requirements.

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 (this course)
Step 5 – Medical Device Software
Step 6 – Post market Surveillance

Content Step 4

• Introduction
• Why Design controls?
• User perspective
• From R&D to market
• Terminology
• Ready to manufacture?
• Keys to success and summary

Duration: 30 minutes

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