US Regulations for EU Companies – Introduction to the FDA Regulations for Medical Devices

by | Jul 25, 2023 | Upcoming Trainings

Speaker: Paige Elizabeth Sutton-Smith, Project Associate

Date: October 3rd-4th 2023, Online

Duration: 6 hours | 2x 3:00 – 6:00 PM CEST, 9:00 – 12:00 AM EDT

Training Objectives:

This training will introduce the FDA regulations for medical devices, with a focus on companies in the EU looking to transition to the US market. The training is directed towards any employee involved in quality assurance, regulatory affairs, and research and development, but is suitable for employees in any field looking to enhance their knowledge of the FDA regulations.

Training Content:

  • Overview of US Regulations, with a focus on 21 CFR Part 820
  • Discussion of key differences between EU and US regulations
  • Exercise: building a DHF from your existing documentation
  • Introduction to Recognized Consensus Standards
  • Identifying the gaps in your EU QMS for US market readiness
  • Preparing for the FDA inspection: what to expect

Training Format:

  • Presentation with interactive discussions
  • Exercises during the training
  • End of training assessment (participants will receive training certificate)


EUR 625 incl. course material and certificate

More Info & Registration: