83 - "How Do I prepare for a 510(k)?" - How Do I Get a 510(K) Series

Episode 83

0:00 - Intro
3:36 - COVID Connect (COVID Metrics)
4:27 - "How Do I Get a 510(k)?" For all the cool guests and interesting topics we've covered in the last 80 episodes, we were drawn up short by the simplicity of a question we received recently... "how do I get a 510(k)?" Sure, we've talked a lot about FDA submissions and medical device development on the show (and often in great depth) but for the next four weeks leading up to Thanksgiving break, we're going to step through this important and fundamental question from square one. We'll cover:

Friday October 29th - "How do I know if a 510(k) is right for me?"
Friday November 5th - "What goes into a 510(k)?"
Friday November 12th - "How do I prepare for a 510(k)?"
Friday November 19th - "What happens after I file?"

For everyone engaged in the process of developing a medical device, this series within a series is not to be missed. Your questions are welcome, and we'll field them throughout!

56:19 - Q+A
CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

Видео 83 - "How Do I prepare for a 510(k)?" - How Do I Get a 510(K) Series канала MedTech Crossroads