Right Submission Product Suite

 

 
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510(k) submissions

Right Submission's 510(k) platform is a SaaS-based tool that creates high quality 510(k) submissions ready for submission and meeting FDA’s requirements. It utilizes a guided process reducing resource requirements, cost and time to submission.

 

 

 

 

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. 

 

medtech document managment

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.