Episode Thumbnail
Episode 50  |  30:35 min

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50  |  30:35 min  |  11.07.2019

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

00:00
00:00
This is a podcast episode titled, Why the 510(k) Process Is So Stressful & How You Can Help Streamline It. The summary for this episode is: My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. Juan Carlos and his team are medical device professionals who spent the late nights writing and formatting 510k submissions just like the rest of us. The hours lost creating submissions for the FDA inspired Juan Carlos to build a software that makes 510k submissions easier. The product is called Right Submission. Juan Carlos tells me about his “lightbulb moment” and why he believes the 510k process is old fashioned and in need of some upgrading. He also explains what exactly his product can do to make your next 510k submission painless. Here are this episode’s highlights: ● The 3 reasons why 510k submissions are stressful. ● The old fashion submission process that really hasn’t changed much. ● The 3 things Juan Carlos believes need to change in the 510k submission process. ● How Right Submission changes this process for the better. ● How Right Submission works.
My guest today is Juan Carlos Serna, the co-founder of Right Submission. If you have been in the medical device business very long you know that 510k submissions for the FDA are a long, tedious, frustrating, and all round painfully experience. Juan Carlos and his team are medical device professionals who spent the late nights writing and formatting 510k submissions just like the rest of us. The hours lost creating submissions for the FDA inspired Juan Carlos to build a software that makes 510k submissions easier. The product is called Right Submission. Juan Carlos tells me about his “lightbulb moment” and why he believes the 510k process is old fashioned and in need of some upgrading. He also explains what exactly his product can do to make your next 510k submission painless. Here are this episode’s highlights: ● The 3 reasons why 510k submissions are stressful. ● The old fashion submission process that really hasn’t changed much. ● The 3 things Juan Carlos believes need to change in the 510k submission process. ● How Right Submission changes this process for the better. ● How Right Submission works.

More Episodes

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis