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US Regulation of Medical Devices




London, United Kingdom


25 Sep 2019 - 27 Sep 2019

Reference No: T1907363-TOP

Apply for this event

Key points about this Training Event

  • This course will enable you to:
  • Understand the global importance of the US medical devices market and the history and context of medical device regulation in the US
  • Demonstrate a critical understanding of the US medical devices regulation, processes and procedures
  • Critically evaluate the different routes into the US medical device market and the regulatory requirements and processes for each
  • Make sound judgements in the absence of complete data and communicate their conclusions effectively
Event Description

Course Outline:

This Masterclass will cover:

  • The US Food, Drug and Cosmetics Act
  • The structure and mission of the FDA, device classification in the US
  • Pre-market notification and approval and the establishment registration
  • Device listing
  • Quality system regulation
  • Labelling
  • Medical device reporting and combination products
  • Further information on FDA audits and enforcement and the key difference to the EU systems

When & Where?

25 - 27 September 2019
Start Day 1: 14:00  End Day 3: 16:00

TOPRA Office
6th Floor
3 Harbour Exchange
South Quay
E14 9GE


Course fee for delegates £1,700.00 plus 20% VAT

Applicant Requirements
  • Students of the MSc programme
  • Delegates from the regulatory affairs industry who wish to develop their knowledge of the requirements of medical devices in the US market
  • Delegates from allied industries who wish to have a comprehensive understanding of the subject
Reference No: T1907363-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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