Genesys presents webinars regularly in a variety of forums, including the NSW Active MedTech Community. Following are links to those that are available publically.
This presentation is a high-level overview of the product development process for active medical devices. We explain how active devices are different from inert MedTech, the range of service providers needed to bring your product to life and the complex web of quality systems, regulatory processes and product certification. This webinar is aimed at people considering developing a medical device and service providers wanting to understand the big picture outside of their field.
Software and electronics is what makes a medical device "active". This presentation breaks down the hardware development process for electronics as well as the corresponding firmware and software development process. An overview is given of the IEC 60601-1 standard for medical electrical equipment and the IEC 62304 standard for medical device software. The webinar is presented by Genesys CEO Geoff Sizer. Geoff has over thirty years of experience designing electronic devices.
At the heart of designing a medical device is the need to carefully manage the design process so that the final product meets the original needs and intended use. Design Control refers to the use of procedures and plans to control and record the development of a medical device. Design controls are often perceived as an annoying overhead. However, properly applied they lay the foundation for a smooth pathway to compliance and certification, as the CEO of Genesys Electronics Design explains in this presentation.
In this session of the NSW Active MedTech Community we collaborated with Venture Cafe Sydney to brainstorm what it would take to rapidly develop an Automatic Ventilator from scratch, in Australia. The discussion worked with real requirements for ventilators that have been published by governments at the height of the Covid-19 pandemic. A plausible design was presented and a panel of experts were invited to make comment, along with the audience.