No matter where you are in the design of your medical product, it is beneficial to follow a proven design process to reduce risk and have the proper documentation in place for FDA submittal.
During this Lunch & Learn, Simplexity Product Development CEO Dorota Shortell and biomedical engineer and Director of Business Development Scott Jarnagin will walk through the steps of a typical design process for a medical device compared to non-regulated devices. Common steps of the design process will be discussed: initial concept, developing a product architecture, building prototypes, and iterating the design to be ready for manufacturing release. Case studies of devices and products that Simplexity engineers have designed will be explored, from medical instruments and wearables to high volume consumer products. By the end of the discussion it will be clear to the audience how the development of non-regulared devices and ISO-13485 controlled medical devices differ, and which steps they have in common.