Right Submission

Medical Device Regulatory submissions

done faster, done smarter.

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View our 30 second video explaining why Right Submission's 510(k) software allows you to submit a higher quality submision sooner and will save you time and money.

Right Submission’s 510(k) software

is a SaaS-based tool that creates high quality 510(k) applications that meet FDA's requirements and are ready for submission. Through our guided process, you will improve resource utilization and reduce cost and time to submission.

The first 510(k) submission prepared with the Right Submission platform was cleared by the FDA 3.2 times faster than the average clearance time: 123 days less than the average.

Sign up for a live demo today.

 
 
 
The Right Submission team and software enabled us to quickly and efficiently create and submit our 510(k) submission.
— Kevin McMahon, CEO, SOLX Inc.
The Right Submission platform and team enabled us to compose a 510(k) with clinical data within ten days and we obtained first pass screening acceptance in six days.
— Brian Young, SVP, Quality and Regulatory, Prytime Medical Devices, Inc.
As someone who has never filed a 510(k) before, Right Submission made the process remarkably straightforward. Our submission was over 900 pages, and I can’t imagine assembling all those documents without Right Submission. Furthermore, we passed the FDA Acceptance Review on our first try.
— Stephen Kita, Project Engineer, ZSX Medical, LLC

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