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. You’ll gain practical insights to help streamline documentation, improve compliance efficiency, and accelerate your path from concept to commercialization. 

This free webinar will also provide guidance and insights for what companies outside the U.S. have to navigate to get their device into the U.S. market, in addition to regulatory strategy, such as considerations for fundraising, market access (reimbursement), product distribution, and more.

What You’ll Learn:

1. FDA Framework and Compliance Foundations

• • How U.S. regulatory expectations differ from global standards like ISO 13485 and MDR
  • Understanding device classification, and the FDA pathways to market
  • The impact of incomplete or misaligned pre-market documentation that delays time to market

2. Regulatory Pathways and FDA Engagement

• • Key distinctions between 510(k), PMA, and De Novo submissions, and considerations for FDA breakthrough device designation.
  • How to use the FDA’s Q-Submission program to get early feedback and reduce risk

3. Building a Scalable Quality Management System

• • Combining ISO 13485 and 21 CFR 820 requirements into a unified, compliant QMS
  • Leveraging a modern eQMS tool for efficient QMS management, including Design Controls and future audits
  • Ensuring Part 11 compliance for electronic records and signatures

4. Product Development and Design Controls (21 CFR 820.30)

• • Overview of Design Control regulations and how they apply to the product development roadmap
  • Integrating risk management and verification and validation (V&V) activities into your design process
  • Organizing a complete and traceable Medical Device File for submission

5. Business and Market Entry Considerations

• • How global organizations should can adapt their commercialization regulatory approach for the U.S. market
  • Fundraising, partnerships, and market access strategies for non-U.S. companies entering the U.S.

Register for free now to gain actionable insights to strengthen your FDA strategy and streamline your path to U.S. market success!