How to register your Medical Device through 510k with Michelle Lott

Medical Device made Easy Podcast · Jan 13, 2020

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510k is a famous way to register your Medical Devices in the US. It is so famous that even if you don’t need it, you will ask to go through it. In this episode, Michelle Lott, Founder, and Principal at LeanRAQA will help us understand everything about 510k. And she is also providing a Slide deck to help you understand all about the FDA process.

We will discuss the different types that are existing:

Traditional

Abbreviated

Special

We will also discuss the way to use standards to confirm that your product conforms to the regulation. Similar to the Harmonized Standards used in…