When: 2-4 December 2025
Where: TOPRA Office, 3rd Floor, City Reach, 5 Greenwich View Place, London, E14 9NN
Day 1 start time: 13:00 BST | Day 3 end time: 16:00 BST
This course is also available to attend in person.
Suitable for
This course is essential for:
- Students of the TOPRA MSc programme;
- Delegates from the regulatory affairs industry who wish to develop their knowledge of the regulation of electrical, electronic and software devices;
- Delegates from allied industries who wish to have a comprehensive understanding of the subject.
Course information
This Masterclass will cover the legislative requirements for electrical, electronic and software devices and apps as well as the current guidance available. The practical considerations of designing, developing or gaining approval for these devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available and very few experienced professionals, the challenges and hurdles will be explored as well as some potential solutions and areas in which more guidance is needed.
Benefits to delegates
This course will enable you to:
- Demonstrate a systematic knowledge, and a critical awareness of the theory and practice of active device regulation
- Be able to determine and justify which classification an active medical device falls into and identify the relevant conformity assessment procedure
- Critically evaluate the regulations and their impact on development, maintenance and marketing of active devices
- Understand the importance and content of key medical electrical equipment and systems safety standards and possess a comprehensive understanding of the unique issues relating to active devices and their use
- Demonstrate the ability to critically analyse the legal documentation and regulatory considerations for active devices
- Application of international and national standards for safety and performance requirements
- Critically appraise and evaluate communications from regulatory bodies and research publications covering active devices
CPD: This course provides 15 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 programme here
Module Leader
Presenters
TOPRA Masterclasses are developed and delivered by a faculty of expert speakers from relevant industry, agencies, notified bodies and other stakeholders, and are validated by the University of Hertfordshire.
Speakers for this Masterclass to be confirmed.
Pricing
| Standard training course registration fees |
| Event Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
£1,900.00 + VAT* |
Standard Price
Non-member |
£2,375.00 + VAT* |
TOPRA MSc Students
|
£1,650.00 + 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
|
£1,425.00 + VAT* |
Government or academic rates
Non-member
|
£1,781.25 + VAT* |
Charities, patient groups, full-time education rates
TOPRA Member |
£950.00 + VAT* |
Charities, patient groups, full-time education rates
Non-member
|
£1,187.50 + 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.