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.


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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.


Right Submission LLC


FDA 510(k) Submission Insider Tips, Tricks and Timelines from a Former FDA Reviewer

Quotes from Juan Carlos:

"We knew we could improve the way medical device technologies get cleared by creating software to facilitate that."

"If you spend enough nights and weekends at the office doing it [510k submission] the old fashioned way, eventually that light bulb is going to fall on your head."

"You put all these factors into a bucket and you stir it, and you get a lot of noise and uncertainty in the process that is 100% avoidable if we as an industry take the time to really reevaluate the way we work and make some changes."

About The Global Medical Device Podcast:

The Global Medical Device Podcast powered by greenlight.guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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