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 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.
- Why Design controls?
- User perspective
- From R&D to market
- Ready to manufacture?
- Keys to success and summary
Duration: 29 minutes