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
Duration: 30 minutes
#8021
€ 190
To tailor the course to your needs, we would like you to take these questions into account when contacting us.