Thousands of quality systems have been created for medical device companies using the ISO 13485 Standard. Unfortunately, ISO 13485 was initially intended for the manufacturing of physical devices. In 2016, ISO 13485 was updated to accommodate software and services, but the resulting standard is less than ideal for SaMD. There are no quality system standards specific to SaMD but we could create one. In this live-streaming video you will get a glimpse into our vision of a quality system designed just for a 100% digital world.