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Go-to-Market Content Bundle for MedTech Teams
Bringing a medical device to market is complex, but it doesn’t have to be chaotic.
We’ve teamed up with the MedTech experts at Rook Quality Systems to package our most valuable tools, guides, and expert insights into one free, ready-to-use bundle.
Whether you’re developing your first device or scaling an existing product line, this collection of resources will help you plan smarter, stay compliant, and move faster.
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What’s Inside?
- eSTAR Submission Playbook: Step-by-step guide to building your 510(k) using the FDA’s eSTAR template.
- On-Demand Webinar: Strategies and insights for 510(k), De Novo, PMA, CE Mark, and pre-submission success covered in the webinar, MedTech Regulatory Submissions Made Easy.
- Early MedTech Startup Package: A snapshot of QuickStart, a purpose-built solution for early-stage MedTech teams.
- Regulatory Resource Cheatsheet: Must-know standards, regulations, and submission programs in one, centralized list.
- Product Development Best Practices: Proven tips to align your regulatory, quality, and commercial strategies.
- Expert-Led Video Clips: Bite-sized insights from our most popular webinars, including design control best practices and startup compliance strategies.
Built by Experts. Designed for MedTech Teams.
This resource bundle is the result of a continued collaboration between QuickVault by Veeva and Rook Quality Systems, two trusted partners in helping medical device companies design, develop, and deliver safe and effective products to patients with confidence.
Whether you’re navigating regulatory submissions, implementing design controls, or building out your QMS for the first time, these resources reflect the combined insights of teams who’ve helped hundreds of MedTech startups scale faster and smarter.
With expertise spanning FDA submissions, CE marking, ISO standards, and quality management, this bundle brings together the best of both worlds: regulatory expertise and modern digital tools to accelerate your path to market.