Roadmap to Market Step 4 – Design and development

 190.00

With the training Roadmap to Market 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.

Description

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.

Content

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

Duration: 29 minutes

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