Course description
Understanding Digital Health and Electronic Products
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 the market for devices will be discussed. In particular, the regulation and approval of software devices is particularly challenging with limited guidance available and 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.
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Suitability - Who should attend?
Suitable for
- Regulatory Affairs Professionals writing reports and dossier sections for these products
- Regulatory Affairs Professionals who wish to develop their knowledge of the regulation of electrical, electronic and software devices
- Those from allied industries who wish to have a comprehensive understanding of the subject
- Those whose companies are considering developing software that may be considered as a device.
Outcome / Qualification etc.
Benefits to participants
- Meet and learn from experts in the field
- Learn by doing- participate in case studies and interactive sessions
- Build a network to support the rest of your career
- Understand all the regulations around electronic devices and software, as well as the development process and controls
Expenses
The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP