When: 29 - 31 May 2019
Where: TOPRA Office, London, UK
Start Day 1: 14:00 End Day 3: 16:00
Course overview
This Masterclass will cover the legislative requirements for electrical, electronic and software devices 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 19 CPD hours upon successful completion
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
Module Leader
Richard Vincins - The Centre for Global Regulatory Compliance
Speakers
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. Specific speaker details will be available closer to the event.
Suitable 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
Pricing
Course fees:
| Type |
Student |
Delegate |
| Standard |
£1500+VAT |
£1700+VAT |
Discounted places
A limited number of discounted places for those working in regulatory or government agencies, academic institutions, charities patient groups of full time education are available at the rates below.
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%
- The registration fee does not include accommodation
- Refreshments and lunch are included in the registration fee
Related courses
Next steps
Module 10: Leadership and Strategic Management in Regulatory Affairs
Module 12: Data Management and Digitalisation of Medical Devices
Module 21: US Regulation of Medical Devices
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