Description: IoT is increasingly finding its way into applications where safety, reliability, security and functional effectiveness are paramount. This includes use in medical, transportation, industrial, defence and even aerospace applications.
The design, development and manufacture of electronics devices and software for use in these environments needs to comply with the requirements of international regulatory standards which go beyond the electromagnetic compatibility and radiocommunications standards which apply to all electronic devices. Such standards apply not only to the characteristics of the finished design, but to the processes used to develop it, including risk management.
Rather than being seen as a burden, compliance with regulatory standards should be seen positively, as a way of enhancing product quality, which indeed their purpose. The aim should not be “to comply with the standard”, but to “develop a safe, reliable, high quality product”.
The presentation will draw on experience gained in taking an electronics and software development team through the process of certification of its Quality Management System to ISO 13485 for medical devices – essentially ISO 9001 “on steroids”. Lessons learned can be usefully extrapolated to product development for other critical applications, and to enhance the quality of less critical commercial and consumer product designs for minimal development overhead.
About the Presenter: Genesys founder and CEO Geoff Sizer has a lifelong passion for electronics and technology, and an ongoing commitment to the electronics engineering profession. He has more than 35 years experience in electronic product development ranging from complex systems to simple consumer goods for a diverse range of industries and applications. Geoff is a Fellow of Engineers Australia and a Chartered Professional. As a former President of the IREE, Geoff was instrumental in the formation of the ITEE College in Engineers Australia and is its immediate past chair. He has championed the formation of the Applied IOT Community of practice. During his career Geoff has acted as a Director or Chief Technical Officer for several leading technology firms including Advanced Systems Research Pty Ltd, Advanced Spectrum Technologies Pty Ltd, EMC Assessors Pty Ltd, Telezygology Inc and Embertec Pty Ltd