What is QuickStart?

A compliance shortcut without the shortcuts. QuickStart is a ready-to-use regulatory and quality solution that gives MedTech startups the structure you need to launch, scale, and sustain success in the market.
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What's Included in QuickStart?

  • Fully Validated eQMS: Pre-configured with FDA, ISO, and GxP best practices, eliminating implementation and setup time.
  • Comprehensive Documentation Package: Pre-built, customizable SOPs, templates, and training materials included for faster approvals
  • Regulatory & Quality Support: 5 hours per month of dedicated QA/RA expertise to help your team navigate compliance challenges and avoid pitfalls.
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Why Choose QuickStart?

QuickStart isn’t just about getting your device to market—it’s about keeping it there. While other systems stop at submission, QuickStart supports your device through every stage of its lifecycle, ensuring regulatory compliance and operational excellence long after approval.

Compliance Without Delays

No setup, no gaps, no wasted time. QuickStart is ready to use immediately, giving you a validated foundation from Day 1.

Accelerate Your Regulatory Submission

QuickStart keeps every required document organized, automates workflows, and ensures submission readiness—helping you avoid costly submission mistakes and approval delays.

Built to Scale With You

From early-stage compliance to full-scale production, QuickStart grows with your company—so you never have to switch systems or start over as your needs evolve.

Frequently Asked Questions

Launch Faster. Scale Smarter. Stay Compliant.

Your competition isn’t waiting—and neither should you. QuickStart provides MedTech companies with the compliance foundation it needs to bring devices to market and keep them there.