Machine learning systems can fail in unusual and unexpected ways, when compared to traditional software products. This course will highlight those differences and will also provide a snapshot of the current standards and regulatory landscape associated with the risk of machine learning enabled medical devices.

We recognize the needs are changing for clinical engineers across the world to ensure the smooth operation of devices that are fundamental to patient care. Through ongoing focus groups, research, and recent conversations at the AAMI eXchange 2024, we understand the hurdles, challenges, and trends are impacting you the most. In this session, we’ll discuss the insights that are driving change at GE HealthCare within Patient Care Solutions as we support you and your teams in keeping your fleet of biomedical devices completely ready for care.

The FDA recognizes the benefits of harmonization with other regulatory authorities, and it has determined that ISO 13485:2016, the globally recognized standard for a medical device organization’s QMS, is substantially similar to the current version of 21 CFR Part 820 which became effective in 1996.

SaMD (Software as a Medical Device) is one of the fastest growing types of Medical Devices in the world.  This is creating a unique situation where traditional software companies are now becoming Medical Device Manufactures (MDMs) and traditional MDMs are developing more and more software.