Address issues relevant to mobile platforms, including OS compatibility, responsive design and cybersecurity.

Properly classifying your SaMD is crucial as it determines your medical device path to the market.

Software that meets the definition of a medical device is subject to a complex set of requirements.

Developing medical devices under a quality management system for the FDA can be a complicated and subtle process with tremendous variability. The leading mitigatable risk to budget and schedule comes from minimizing the impact of change during the development process. This presentation will address common categories of change and how to minimize or even benefit from the disruption.

Join industry experts from ICS and Greenlight Guru to discuss recent updates and changes in SaMD, regulatory and quality considerations in growing technologies including AI, mobile and cloud and three steps to take today to prepare for the future.