The Medical Device Introductory Course

The Medical Device Introductory Course
This training course will provide those new to medical device regulatory affairs with an understanding of the regulatory requirements for medical devices in the EU and UK. The Medical Device Introductory Course has been put together by practicing medical device regulatory affairs professionals and is in-demand from senior leaders in regulatory affairs who need to get their teams up to speed on current European medical device regulatory practices.



When
: 16-18 June 2025
Where: TOPRA 3rd Floor, City Reach, 5-6 Greenwich View Place, London, E14 9NN
Day 1 start time: 10:15 BST (CET+1) | Day 3 end time: 16:15 BST (CET+1)

Suitable for

This course is essential for:

  • People new to medical devices and in vitro diagnostics (IVDs), usually with 1-2 years’ experience;
  • Those who want a broader understanding of medical devices;
  • Anyone in medicines regulation who work with drug-device combination products;
  • Those working in other areas of regulatory affairs who are looking to move into, has an interest in, or would like a greater understanding of medical devices.
Note: this course is also Module 13 of the MSc Regulatory Affairs.

Course Overview

TOPRA's Introductory Courses have been designed to provide a firm foundation to your career in regulatory affairs. Under the guidance of our medical device regulatory affairs expert speakers, you will emerge a more confident and proactive professional who will be able to:  

  • Understand and comply with medical device regulations 
  • Classify medical devices 
  • Assess borderlines issues 
  • Establish and maintain an internal audit and supplier audit programme
  • Prepare and manage a third-party audit 
  • Recognise diverse country requirements 
  • Advise on how to conduct a clinical investigation  
  • Implement a copy approval process. 

Benefits for delegates

Delegates will understand the:

  • Role of the essential requirements / harmonised standards and how to demonstrate conformity 
  • Different conformity assessment routes and how to select the most appropriate route for their product 
  • Role of risk management in pre and post market phase and be able to advise on a risk management policy and procedure. 
  • Need for clinical evidence for CE marking  
  • Needs of payers and how to include these as part of the development of the device regulatory package 
  • Key elements within a PMS system 
  • Criteria for vigilance and the Competent Authority (CA) expectations 
  • Minimum requirements and CA expectations for implementing a Field Safety Corrective Action (FSCA) 
  • Impact of marketing literature on regulatory status 
CPD: This course provides 23 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.

Programme 

You can view and download the draft programme here.

Module Leader

       

Richard Vincins, Principal Strategy Consultant, NAMSA 


Presenters

Presenters for this training course include:                        

  • Peter Bowness, Vice President Quality & Regulatory, International, GE HealthCare 
  • Howard Dobbs, Principal Consultant, Howard Dobbs Consulting Ltd

Pricing


 Standard training course registration fees
 Event Registration Type Price (GBP)
 Standard Price 
 TOPRA Member
£2,200.00 + VAT*
 Standard Price
 Non-member
£2,600.00 + VAT* 
 TOPRA MSc Students
  
£1,650.00 + VAT*

Save on the full cost of membership and £180
on the price of your training
course when you add TOPRA membership to your booking (membership fees are exempt from VAT).
*VAT, where applicable, is charged at the rate of 20%.
 
 Discounted training course registration fees
 Event Registration Type Price (GBP)
 Government or academic rates
 TOPRA Member
£1,650.00 + VAT*
 Government or academic rates 
 Non-member
£1,950.00 + VAT*
 Charities, patient groups, full-time education rates
 
TOPRA Member
£1,100.00 + VAT*
  Charities, patient groups, full-time education rates
  Non-member
 £1,300.00 + VAT*

Places are also available for those in low-income countries as defined by the World Bank.
*VAT, where applicable, is charged at the rate of 20%.
 

Please email meetings@topra.org for a discount code before making your booking.

Terms and conditions

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

 
When
16/06/2025 - 18/06/2025
Where
TOPRA Office London UNITED KINGDOM
Sign in or create an account to register Last day to register is 15/06/2025
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