medical device regulatory submissions
done faster, done smarter.
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.
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.
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.
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.
Member of MassMEDIC