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Design Regulatory QMS

The All-in-One Platform
to Get Your Medical Device to Market

QuickVault unifies product development, regulatory compliance, quality management, and operations in a single, purpose-built cloud solution for MedTech teams.

DesignRegulatoryQMS

A Unified Solution

MedTech success doesn’t stop at regulatory approval.
QuickVault is designed to support your entire product lifecycle, ensuring efficiency, quality, and compliance at every stage of your journey.

Design

Manage your design controls, design reviews, and risk assessments in a fully compliant, validated environment.

Track every decision, collaborate seamlessly, and ensure you’re developing a safe product that meets regulatory standards from the start.

Start Designing

Regulatory

Streamline your product submission, regulatory interactions, and product registration with built-in compliance workflows.

Keep all documentation organized, track submissions in real-time, and respond to regulatory inquiries with ease.

Manage Submissions

Quality Management

From document control to training and supplier management, internal and external stakeholders can collaborate in a secure, easy-to-use platform.

Maintain full visibility into quality processes, automate compliance tracking, and mitigate risks before they become costly issues.

Streamline Production

The Device-To-Market Platform for MedTech

Bringing a medical device to market is just the beginning. True success requires a seamless approach to design, regulatory submission, and ongoing production—all while maintaining compliance and quality at every stage.

Compliance Without Complexity

Fully validated and compliant with 21 CFR Part 11 / EU Annex 11.

Day 1 Ready

No lengthy implementations or customization projects. Get up and running immediately.

Purpose Built for MedTech

Designed specifically for small and emerging medical device companies, scaling with you as your product and business grow.

All-in-One Platform

Intuitive software that integrates design, regulatory submission, and production into a unified, easy-to-use platform.

With you every step of your MedTech journey

Your path to market—and beyond—starts now.

Our Solutions

MedTech Innovation Without Roadblocks.

Compliance Without Compromise.

QuickVault helps early stage MedTech companies bring devices to market and keep them there by providing the right tools at every stage of growth.

Whether you’re looking for a formal design control system, preparing for a product submission, or managing post-market activities, QuickVault is built to scale with you.

Explore Our Solutions

We’re A Trusted Authority in Medtech

UPCOMING WEBINAR

FDA Readiness & U.S. Market Entry: A Roadmap for Global MedTech Innovators

Bringing a medical device to the U.S. market can be complex, whether you’re an emerging MedTech startup or a global manufacturer. Between ensuring you have a robust QMS, navigating FDA regulations, developing your device in accordance with design controls, and achieving 510k clearance or PMA, it’s critical to start with a clear strategy that positions your device, and your business, for long-term commercial success.

Join experts from Rook Quality Systems and QuickVault by Veeva for a comprehensive walkthrough of the regulatory and operational steps required to prepare your device for FDA submission and achieve U.S. market success.

Register Now