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USA / FDA – Fundamentals of export compliance for MD

This course provides an essential overview of FDA requirements for accessing the US market, focusing on roles, responsibilities, and basic obligations needed to navigate the certification process and obtain marketing authorization for medical devices.

This course belongs to the “International Markets & Export Compliance” line.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course provides an essential overview of FDA requirements for accessing the US market, focusing on roles, responsibilities, and basic obligations needed to navigate the certification process and obtain marketing authorization for medical devices. It is designed to support companies in the initial stages of entering the US market, helping to reduce early errors and regulatory challenges.

Key Points

  • FDA export compliance fundamentals

  • Roles and responsibilities

  • Basic obligations for marketing authorization

  • Reducing early regulatory errors

Structure

4-hour course.

Live streaming or on-site at your company, based on your needs.

Would you like to host this course at your company?

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