Free eBook
Mastering eSTAR: Your Step-By-Step Guide to Seamless Submissions
This comprehensive playbook is designed to guide you through every step of the FDA’s eSTAR program. Whether you’re new to eSTAR or looking to optimize your submission process, this ebook will provide you with the knowledge and tools to ensure your submission is smooth and successful.
Download your free PDF copy of the ebook now!
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What’s Included in this Free eBook?
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- A complete overview of the FDA eSTAR program and its goals
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- Key insights on user fees, exemptions, and requirements
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- Step-by-step instructions for filling out and submitting your eSTAR
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- Demo images and tips to help you navigate the CDRH portal
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- Direct links to useful regulations and clear descriptions of FDA requirements
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- And much more!
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Need Help Getting Started with Your FDA eSTAR Submission?
The eSTAR submission process can feel daunting, but you don’t have to navigate it alone.
QuickVault by Veeva and Rook Quality Systems have teamed up to create Mastering eSTAR: Your Step-By-Step Guide to Seamless Submissions—a practical, expert-driven playbook designed to help MedTech companies confidently prepare a medical device submission through FDA’s eSTAR program.
Inside, you’ll find clear guidance, proven strategies, and actionable tips to make your submission process more efficient, compliant, and FDA-ready. Whether you’re tackling your first eSTAR or optimizing a repeat submission, this free guide is your roadmap to success.