Vault Submissions streamlines global regulatory submission management, giving medtech companies complete control over submissions' planning, authoring, and tracking. A global, modern cloud software application eliminates the need for multiple systems and spreadsheets, enabling regulatory teams to easily cross-link documents to source files, automate tasks, create reports, and manage HA interactions in one place.
Real-time visibility into the progress of regulatory submissions through intuitive reports and dashboards
Faster and more efficient submission document authoring, assembly, collaborative review and approval
Enable global alignment across affiliate submissions and Health Authority interactions
Connect end-to-end regulatory processes and improve efficiency with the Vault RIM Suite.
Align content taxonomy (e.g., document types, subtypes, properties, etc.) with industry standards like GHTF STED, and the IMDRF Market Authorization Table of Contents and extend to meet specific business needs.
Auto-generate a table of contents for major regulatory submissions, add planned content, report on submission status in real-time, and reuse content plans globally.
Replace manual processes with flexible workflows and lifecycles that guide submission authoring, review and approval. Authorize individuals to easily change in-process workflows by adding, removing or emailing participants.
Provide authorized users with access through a single, secure cloud location, eliminating the need to bring external users behind the corporate firewall, issue laptops or provide network IDs.
Simultaneously edit documents alongside multiple Vault users while utilizing the full co-authoring capabilities provided by Microsoft Office™.
Compile and publish reports, such as Clinical Study Reports and Clinical Evaluation Reports. Create hyperlinks that are independent of report structure so they can be used earlier in the process during document reviews.
Drill down through interactive dashboards to narrow in on the exact source of delays. Take action directly from the reports to address hold-ups quickly and stay on track for submission deadlines.
A Single Authoritative Source for Regulatory Submissions Content
Jay Crowley: UDI Demands on Medtech Organizations
Perspectives from Cook Medical and Exact Sciences: Regulatory transformation
MDR's impact on Europe's innovation capabilities