Regulatory Pathway: How to reach the US market? [510k exempt]

Nov 15, 2022 · 33m 50s
Regulatory Pathway: How to reach the US market? [510k exempt]
Description

If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that...

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If you are willing to reach out to the US there may be multiple strategies. We will talk today about MysteryVibe that started to evaluate the market and identified that their product is class IIa in EU and Class II in the US. But in the US this is 510k exempt so let's here their journey. The post Regulatory Pathway: How to reach the US market? [510k exempt] appeared first on Medical Device made Easy Podcast. Monir El Azzouzi
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Author Monir El Azzouzi
Organization Monir El Azzouzi
Website -
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