When: 11 June 2024
Time: 08.30 - 17.00 BST (CEST+1)
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 presentations 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.
What you will learn
- 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
- 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.
CPD: This course provides 8 CPD hours upon successful completion.
To learn more about why Continuing Professional Development is important, visit our Lifelong Learning page.
The previous programme is available to download HERE
The course will be presented by Richard Vincins
- 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
A limited number of discounted places are available at the rates below.
Please email us at email@example.com for a discount code before making your booking.
|Those working for regulatory agencies, government agencies or academic institutions
|Those working for charities, patient groups or are in full-time education
*VAT, if applicable, is charged at VAT rate of 20%
Terms and conditions
By booking a place on this course you are agreeing to the training terms and conditions