Medical Devices (includes In Vitro Diagnostics)
Human Factors and Usability are becoming more relevant to today’s regulatory professionals. Identifying key user needs to input into product design and capturing this information in the most efficient way to inform design is of paramount importance, especially with increasing innovation within the devices sector and the ever-changing regulatory landscape.
This session will discuss strategic approaches to maintaining the usability aspects of the development process whilst meeting regulatory expectations for existing and novel applications within the medical device sector, especially those not covered specifically by regulatory guidance. Additionally, the session will include learnings from other industries such as software, reduced risk products and consumer products, including how knowledge can be applied across different regulated sectors.