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US Regulatory Affairs for Medical Devices

Course summary
2 days
1,595 GBP excl. VAT
City of London
Next available date: 27/11/2019 09:00 - City of London
Open / Scheduled

Course description

The US is a huge market for medical devices, yet there are a number of key differences between FDA procedures and those in Europe.

This essential course will provide you with a comprehensive foundation in US regulatory affairs to make your submission a success. Over two days, 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.

Delegates will be able to cement this knowledge through interactive workshops.

Suitability - Who should attend?

  • Regulatory Affairs professionals with previous experience in medical devices, but who may be unfamiliar with the US market
  • Those moving into Regulatory Affairs from other areas within a medical device company  (Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on US regulatory affairs for medical devices

Training Course Content

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

About provider


PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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