Right Submission Product Suite

 

 

510(k) submissions

Right Submission's 510(k) platform is a SaaS-based tool that creates high quality 510(k) application ready for submission and meeting FDA’s technical and style requirements. It utilizes a guided process reducing resource requirements, cost, and time, strengthening the content of your submission and streamlining workflows.

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CLINICAL STUDY REPORTS

Our software guides you through the creation of a CSR pursuant to the ICH E3 guidelines for Clinical Study Reports. It helps build high quality content and allows for easy integration and management of your clinical data analysis and Section 16 appendices. You can then seamlessly merge your completed CSR into the 510(k) platform for premarket clearance.

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CLINICAL EVALUATION REPORTS

MEDDEV 2.7/1 Rev 4 requires some products to update CERs annually. Right Submission's customizable CER software helps your team work smarter not harder to produce up to date and compliant CER reports. 

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medtech document managEment

Share and control your documents with revision control and visualization.

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design control documents

Manage and share your design control documents.

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regulatory opinion tracker

Keep up to date with the latest FDA regulatory guidance and opinions.

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