Right Submission's 510(k) Platform
Right Submission’s 510(k) platform is a SaaS-based tool that creates high quality 510(k) submissions for medical device companies in a guided process reducing resource requirements, cost and time to submission.
Our platform produces an e-copy compliant 510(k) submission ready for submission to the FDA. It automatically applies FDA's technical and style standards and guidance in a step-by-step guided process. Global tokens allow changes to be made automatically across the entire submission. Your resources will be focused appropriately.
We provide extensive help guides and links to regulations, standards and guidance. The software includes a database of standards for inclusion and equivalent devices for rapid addition. Your submission will be created faster and better.
The platform allows your team to collaborate effectively. Everyone has access to all the material assigned to them. Contributor, reviewer and project manager roles are assigned. The software is cloud based and all work product is accessible from anywhere with internet access from our secure server to authorized users. The database contains version history and allows rollback. Previous work can be reused. Your team will work seamlessly and effectively.
The software reports your progress allowing effective project management and reporting to stakeholders. Your stakeholders will be informed and you can course correct earlier.