The NSW Smart Sensing Network, together with the University of Wollongong and Genesys Electronics Design, host this industry seminar for researchers interested in developing commercially scalable products with embedded electronics.
The development of medical technologies with embedded electronics involves a far greater regulatory burden than most other devices. The process of taking a concept through to a commercially scalable product, ready for global distribution, is full of pitfalls. A key challenge is the mandatory requirement for user needs, traceability of any software developed, as well as demonstrating both the electrical safety and essential performance of the device. While many have a theoretical knowledge of the full gamut of regulatory requirements, only an experienced commercial electronics designer understands how this translates into scalable and manufacturable designs for embedded hardware and software.
This seminar provides an introduction to the commercialisation of electronic medical devices, with a focus on how the regulations relate to engineering design processes. The key takeaway will be an appreciation of the commercial imperatives you need to consider early in the product development process.
Lunch will be provided. Registration is essential. Register here.
About the presenter: Geoff Sizer is the CEO of Genesys Electronics Design – a design house specialising in the development of active medical devices leveraging Internet of Things technologies. The company has ISO 13485 certification for the design of active medical devices. The company has developed a system of modularised software and hardware that has been developed according to the medical standards. This platform can be adapted to the development of any medical device and encompasses medical sensors, edge computing, user interfaces, cloud processing, mobile apps and multiple communication protocols. Geoff has over 30 years of experience in design electronic devices and has specialised in the medical device space over the past several years.