Course overview

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

Programme

You can view and download an example programme based on previous courses here

Module Leader

• Richard Vincins - VP Global Regulatory Affairs, Oriel STAT A MATRIX

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. In addition to the module leader(s) listed above, previous speakers for this course include:

• David Grainger - Device Specialist, MHRA

• Miguel Amador - Business Creation Lead, EIT Health InnoStars

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  

Standard

• TOPRA MSc students: £1,500 + VAT*
• Delegate: £1,700 + VAT*

Discounted places

A limited number of discounted places 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: £1,275 + VAT*
• Those working for charities, patient groups or in full-time education: £1, 275 + VAT*

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

Terms and conditions

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