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Navigating the US market: strategies for success

About this webinar


The FDA and its Quality System Regulation (QSR) are the gatekeepers of the largest medical device market on Earth.
Crack the US market, and your medical device takes on a new lease of life.

But the FDA won't throw open the doors for just anyone, and the intricacies of 510(k) and PMA submissions offer an extra layer of challenge.

Join our step-by-step guidance session to unpick and master every challenge, hurdle and regulatory obstacle standing between you and long-term US market success.


What you'll learn:


  • The end-to-end process for launching your medical device in the USA, how long it will take, and which route is right for you

  • The key steps to American expansion, from classifying your device to completing a 510(k) and preparing for FDA inspections

  • Tips and best practice for a right-first-time strategy that makes the FDA happy

Your Presenters

Profile
Leticia Cubero Dominguez
QA & Regulatory Manager
Ferronova
Profile
Jason March
Senior Quality Specialist
Qualio
  • Profile
    Leticia Cubero Dominguez
    QA & Regulatory Manager
    Ferronova
  • Profile
    Jason March
    Senior Quality Specialist
    Qualio
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