(Veeva: Pleasanton, CA) -- QuickVault by Veeva, the leading all-in-one platform purpose-built for small medtech, has announced a major enhancement to its cloud-based platform that includes robust new features to 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 a 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 and submission approvals, 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

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, design verification and validation, and risk management directly into the submission.

Submission templates: Jump-start your process with ready-to-use, customizable templates, including:
• eSTAR IVD and non-IVD
• EU IVDR and MDR
• IMDRF IVD and non-IVD
• PreSTAR

Submission preparation and 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 U.S. Food and Drug Administration 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,” says Seth Goldenberg, president of Veeva MedTech. “By centralizing regulatory activities within QuickVault, and 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 at no additional charge. Both current and new customers will have access to this functionality as part of the validated application and standard update process.

To learn more about QuickVault’s new regulatory and submission management capabilities, schedule a personalized demo.