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Right Submission:

medical device regulatory submissions

done faster, done smarter.

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Right Submission provides consulting, software and hybrid consulting+software to both early stage and established medical device companies.


Founded by regulatory experts, Right Submission was the first company to bring a customizable SaaS regulatory submission platform to the medical device market.

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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.

 

Our expertise and software is focused on medical devices and IVDs, including AI based Imaging tools and SaMD (Software as a Medical Device).

We help our clients with PreSubs, 513(g), 510(k), De Novo and PMA Submissions. We also provide solutions for Clinical Study Reports, Clinical Evaluation Reports and other Clinical work.

 
 

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.


TESTIMONIALS

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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