Roadmap to Market Step 3 – Medical Device QMS Introduction

 190.00

With the training Roadmap to Market Step 3 you will get a first insight in the regulatory landscape that surrounds Quality management Systems for Medical Devices. It covers mainly European and US requirements but gives a brief description of other International activities in the regulatory area.

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 3) you will get a first insight in the regulatory landscape that surrounds Quality management Systems for Medical Devices. It covers mainly European and US requirements but gives a brief description of other International activities in the regulatory area.

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

  • What is a medical device and why is it different to other products
  • How are medical devices classified
  • Regulatory requirements on medical devices
  • How to get a medical device to the market
  • How does it impact daily tasks in a MD company
  • Brief overview of ISO 13485
  • Where can you find out more

Duration: 63 minutes

#8015

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