Developing Medical Devices: Safety Considerations

In the talk titled "Developing Medical Devices: Safety Considerations," we will explore the key aspects to consider when developing medical devices, focusing on safety, reliability, and scalability. We will begin by defining what a medical device is and describing the methodological approach required for its development. Additionally, we will also look at the implications in the development of Software as a Medical Device (SaMD), as it adds additional challenges in this context. Throughout the presentation, we will examine the types of tests that can be conducted to ensure compliance with critical non-functional requirements in different scenarios. We will also explore the migration of these systems to the cloud, an increasingly relevant aspect that accentuates some of these challenges, particularly in terms of security and scalability. This topic is of great importance to professionals in the field, as it provides a better understanding of the impact that these non-functional requirements have on the development of medical devices and SaMD, as well as their migration to the cloud. Through this talk, attendees will gain valuable insights on how to address these challenges and ensure that both medical devices and associated software are safe and reliable in both local and cloud environments. Professionals from other regulated sectors or those developing high-criticality applications may also find reflections of what applies to them and gain valuable insights to export to their domain. Happy testing.