US Regulation of Medical Devices

US Regulation of Medical Devices
Module 21 of the MSc: This Masterclass will provide you with a comprehensive understanding of the US regulatory procedures for medical devices, to enable you to make recommendations about regulatory strategy for the US market. Additionally it will provide you with an understanding of a globally important market in addition to the knowledge of the EU that the rest of the course provides.



When
: 3 - 5 March 2021
Where: TOPRA Office, 3 Harbour Exchange, London, E14 9GE, United Kingdom (Also available as an online course, please click here for more information)
Day 1 start time: 13:00 GMT | Day 3 end time: 16:30 GMT

Course overview

This Masterclass will cover:

  • US FD&C Act and Code of Federal Regulations
  • History, Structure and Mission of the FDA
  • Product Designation and Device Classification
  • Pre-Submissions, Pre-Market Notification & Approval
  • Combination Products
  • Device Listing and Establishment Registration
  • Labelling
  • Quality Systems Regulation and Inspections
  • Medical Device Reporting

Benefits to delegates

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
  • Evaluate the differences and similarities between the regulation of medical devices in the US and EU
  • Be able to make recommendations about entering the US medical devices market and a suitable strategy for doing so. This will include the ability to apply product jurisdiction, device classification criteria and identify relevant regulatory pathways and requirements
  • Make sound judgements in he absence of complete data and communicate their conclusions effectively
  • Critically appraise and evaluate communications relating to medical devices from US regulatory bodies and research publications
CPD: This course provides 19 CPD hours upon successful completion. To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme

The latest course programme will be available soon

Module Leader 

Module Leader will be announced in due-course

Presenter

Jonathan Hughes - Director, JHRA Ltd

Suitable for

  • 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

Pricing

    Course fees*:
    Type Student Delegate
    Standard    £1500+VAT £1700+VAT 

    Discounted places
    A limited number of discounted places are available at the rates below. 
    Please note that discounted places are not valid for those enrolled on the MSc course.
    Please email us at meetings@topra.org for a discount code before making your booking.


    Those working for regulatory agencies, government agencies or academic institutions 
                                       
     £1275+VAT
    Those working for charities, patient groups or in full-time education
       £1275+VAT

    *VAT, if applicable, is charged at the rate of 20%

    Terms and conditions

    Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

    Registration

    Simply log in or create an account and then register using the 'Register Myself' button that will appear below once you are logged in. 

     

    When
    03/03/2021 - 05/03/2021
    Where
    TOPRA Office 6th Floor, 3 Harbour Exchange South Quay London E14 9GE UNITED KINGDOM
    Your company name
    Your VAT country
    Your VAT number
    NOTE
    Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

    Register now