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Electrical, Electronic and Software Medical Devices




London, UK


20 Sep 2018

Reference No: T1803289-TOP

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Event Description

Course Outline:

This course covers regulatory requirements for electrical, electronic, and software devices including current guidance, interpretation, and application of regulations. The practical considerations of design, development, and placement on market for these type of active devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available with continual advancement of technology. 

Challenges and issues concerning active devices and software devices will be explored to discuss and review solutions that are being applied by regulatory professionals. The linkage between the electrical and electronic devices and software devices will also be described, with further presentation on how other processes like risk management, usability, and product life cycle management are linking everything together. Review of key requirements will be made including comparing and contrasting electrical, electronic, and software devices between US, European Union, and other countries.

This course will provide an overview of electrical, electronic, and software devices examining different elements of regulatory requirements including:

  • Definition of “active” devices and components of electromechanical devices
  • Aspects implementing design controls applicable to active devices
  • Consideration of manufacturing activities for these type of devices
  • IEC 60601-1 standard and compliance needs
  • IEC 60601-1-2 standard and compliance needs
  • Safety and essential performance requirements
  • Marking and labelling of electromechanical and software devices
  • Usability and human factors to IEC 62366
  • Programmable Electronic Medical System (PEMS)
  • Linkage of electromechanical devices and software/firmware
  • Software Development Life Cycle to IEC 62304
  • Phases of software development, verification, and validation
  • IEC 62304 and FDA guidance document applicable to software
  • Software as a Medical Device (SaMD)
  • Software of Unknown Provenance (SOUP)
  • Risk management linkages for electromechanical devices and software
  • Networking and cybersecurity of software
  • Workshops and exercises to have regulatory professionals apply practical principles of electrical, electronic, and software devices

When & Where?

20 September 2018

TOPRA, 6th Floor
3 Harbour Exchange
South Quay
London, E14 9GE


TOPRA Member: £675 plus 20% VAT
TOPRA Non-member: £550 plus 20% VAT

Applicant Requirements
  • Any regulatory professional that works with active devices, specifically devices that are electrical powered, contain electronics, driven by software/firmware, or are software only applications
  • Regulatory professional maintaining technical documentation or seeking approval for these types of devices
Reference No: T1803289-TOP
TOPRA is the professional membership organisation for individuals working in healthcare regulatory affairs.
We work with our members internationally to enable and promote excellence across the healthcare regulatory profession.


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