Right Submission Product Suite
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.
design control documents
Manage and share your design control documents.
regulatory opinion tracker
Keep up to date with the latest FDA regulatory guidance and opinions.