FDA Submission Preparation and Filing

Achieving FDA compliance can be complex and overwhelming. Borderless MedDev guides medical device manufacturers through every step of the process with clarity and confidence.

Fast-Track Your Success

Borderless MedDev helps you build a strong, strategic case for FDA clearance. We ensure each submission meets FDA standards and clearly presents your device’s safety. performance and intended use.

From there, we partner with you throughout execution, working directly with test houses and regulators, handling communications, and supporting your team. We create high-quality submission portfolios designed to stand up to review and accelerate your path to market.

What We Help With:

  • Regulatory Strategic Planning

  • Organizing Pre-Submission Meetings

  • Breakthrough Device Program Applications

  • 510(k) Submissions

  • De Novo Submissions

  • 3rd Party 510(k) Submissions

  • Statistical Analyses

  • GUDID Management

The Right Strategy for You

Each company’s path to market is unique. At Borderless MedDev, we understand your goals and tailor a strategic plan for your specific needs.

Our efficient, strategic approach keeps your timeline moving without unnecessary delays. We act as your partner, coach, and sounding board, ready to support you at every turn.

Compliance Without the Confusion

Borderless MedDev works directly with the FDA throughout your submission process. This includes:

  • Arranging and preparing for Pre-Submission (Q-sub) meetings

  • Drafting responses to FDA requests for additional information

  • Communicating directly with reviewers to resolve issues quickly

We speak the language of regulators so you can move forward with confidence.