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TRAINING COURSE: US Regulatory Affairs for Medical Devices

Get a comprehensive foundation in US regulatory affairs to make your submission a success

Delivered by Medical Device Training International (MDTI)

Want To Get To Grips With US Regulatory Affairs for Medical Devices?

Thursday 20th June 2019

This essential course will provide you with a comprehensive foundation in US regulatory affairs to make your submission a success. Delegates will gain a solid understanding of regulatory standards, requirements and submission options and processes, including current hot topics such as software as a medical device.

This one day training course is designed to help you:

  • Understand the scope of FDA regulation
  • Consider the possible approval routes
  • Investigate how devices are reviewed by the FDA
  • Examine labeling and UDI requirements
  • Learn where to find the information you need