2020-05-20 Design Controls for MedTech

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.
The diagram above conveys a sense of simplicity, but the process is one of the most challenging aspects of active MedTech product development. Design controls need to apply very early in the design process, often before startups are even aware of the need for them. Because of the extensive documentation required, they are often perceived as an annoying overhead. However, properly applied, they lay the foundation for a smooth pathway to compliance and certification.
Learning how to implement design controls in a way that does not stifle innovation or incur excessive cost is the focus of this webinar.
In this webinar, the NSW Active MedTech Community coordinator, Dr Tim Kannegieter will interview Genesys CEO Geoff Sizer to discover what's involved.