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Although the process of FDA clearance for Class I and II medical devices is simpler than for medical drugs and Class III devices, the various submission standards are not always obvious or intuitive, and failure to properly navigate them can lead to wasted resources at best and federal prosecution at worst.

Listen to our webcast to learn:  

  • Understanding the classes and corresponding regulatory controls
  • Confirming your device’s classification
  • Identifying predicate devices already cleared for sale
  • Defining your device’s Intended Use
  • Developing a regulatory and strategic pathway

Presented By:

Charlotte Baker, RAC, PMP
Senior Director, Regulatory & Strategic Development, Medical Devices
Charlotte brings more than 20 years experience in regulatory, quality and compliance in the healthcare, biopharma and medical device industries. She also has a proven track record in leading and achieving successful global product submissions/approvals for new products and post-commercialization changes (PMA & 510k).

In her current role, Charlotte is responsible for developing regulatory strategies for client products. She also prepares regulatory submissions for the US FDA, EMEA and other regulatory authorities.

Free Webcast:

Streamlining the Regulatory Path to Market for Low-Risk Medical Devices

Download the webcast now!