QuickVault by Veeva Launches New Regulatory & Submission Management Functionality to Accelerate MedTech Approvals
QuickVault by Veeva, the leading all-in-one platform purpose-built for small MedTech, today announced a major enhancement to its cloud-based platform, which includes robust new features that simplify and accelerate the regulatory submission process for medical device and IVD companies.
The new release includes purpose-driven tools to help MedTech teams create global regulatory submissions directly within the QuickVault platform. This makes QuickVault the first of its kind platform bringing together design, regulatory submission, and eQMS functionality into one simple, easy to use, application for MedTech organizations. This will result in faster product development, submission approvals, and accelerating overall time to market. The submission functionality includes submission preparation, user assignments for submission tasks, and post-submission tracking of regulatory authority interactions.
Immediate benefits for QuickVault users:
- Ease of Submission: Reduce time-to-approval with streamlined workflows, unified with design controls, ready-to-use templates, and automated submission packaging—all designed to simplify the regulatory process.
- Organized Processes: Stay audit-ready at every step with centralized document control and clear task ownership.
- Stronger Collaboration: Enable better cross-functional teamwork with shared templates and transparent task tracking within one centralized location for all submission data.
Key new capabilities include:
- Submission Management: Easily organize submission documents with full version control, individual task assignments, and detailed audit trails for complete traceability. Tie documents from Design Controls, DV&V, and Risk Management directly into the submission.
- Submission Templates: Jumpstart your process with ready-to-use, customizable templates, including:
- eSTAR IVD & Non-IVD
- EU IVDR & MDR
- IMDRF IVD & Non-IVD
- PreSTAR
- Submission Preparation & Package Automation: Simplify submission workflows with task tracking, automated compliance reporting, and one-click submission package generation in a folder structure aligned with global regulatory authorities.
- Regulatory Authority Interaction Tracking: Track and centralize all post-submission communications with the FDA and other global regulatory authorities. Assign tasks to the team to provide additional documents and data as requested by regulatory authorities.
“This release marks a significant step forward in our mission to make regulatory excellence simple, scalable, and accessible to MedTech innovators of all sizes,” said Seth Goldenberg, President of Veeva MedTech. “By centralizing regulatory activities within QuickVault, unifying with design and eQMS capabilities, companies can now reduce submission timelines, maintain audit readiness, and keep projects moving forward with confidence.”
QuickVault’s new Regulatory Submission functionality is included as part of the QuickVault offering at no additional charge. Both existing and new customers will have access to this functionality as part of our validated application and our standard update process. To learn more about QuickVault’s new Regulatory and Submission Management capabilities, schedule your personalized demo.
About QuickVault by Veeva
QuickVault by Veeva is the leading device-to-market solution for small MedTech companies. Built for full device lifecycle support, the platform unifies design, regulatory, quality, and post-commercial operations in one scalable environment — helping teams stay agile, compliant, and ready to grow.
From concept through commercialization and beyond, QuickVault by Veeva gives MedTech companies the visibility and control they need to deliver safe, effective products to patients and succeed at every stage.
Learn more about QuickVault by Veeva
