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EUA and the Impending Transition
- Author: Vários
- Narrator: Vários
- Publisher: Podcast
- Duration: 0:40:25
- More information
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Synopsis
There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Listen to the episode to hear what Kyle has to say about the EUA transition deadline, the potential uses for the EUA going forward, and what companies should focus on if they only started selling medical devices during the EUA.Some of the highlights of today’s show include:Whether there’s an EUA transition deadline yetWhat EUA companies need to be doing right now on the quality side of thingsWhat the EUA transition will look likeHow adverse events need to be documentedThe potential for the EUA as the norm in certain si