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I want to sell my medical device outside of the US. What do I need to know?
If you’ve successfully sold your medical devices within the US, you may be ready to expand your customer base and sell outside the country.
Before you become authorized to sell products to countries within the European Union (EU), for example, specific standards must be in place including: quality management systems, CE marks and more.
The North Carolina Manufacturing Extension Partnership is hosting a webinar designed to help you understand the process of exporting your medical device products to the EU. In this webinar, Darren Reeves, president of DP Distribution & Consulting, will discuss:
What quality system is required?
Focus on EU
What is the MDD/MDR?
What is a CE mark?
What are the steps to a CE mark?
What is an authorized representative?
How long does it take?
How much does it cost?

00:39:00

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