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US Regulation of Medical Devices

Price

£1,700

Location

London, United Kingdom

Date

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?

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

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

Cost?

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.

Email info@topra.org

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