Continuous Operational Assurance: the missing discipline for software-defined medical devices
Software-defined medical devices are transforming healthcare and they also challenge many of the assumptions behind traditional device development.
If software can evolve after deployment through over-the-air updates, AI models, and increasingly connected ecosystems, is one-time verification still enough? Or do we need a new way of thinking about assurance throughout a device’s operational life?
In this conversation with EPDT and senior editor Mike Green, Percepio’s CEO Andreas Lifvendahl discuss why he believe continuous operational assurance will become an essential complement to verification and validation. They explore how runtime observability can help manufacturers understand software behaviour not only during development, but throughout clinical trials and real-world operation.
Among the topics covered
• Why software-defined medical devices require lifecycle thinking rather than point-in-time certification.
• How connected devices introduce new challenges around timing, concurrency and system interactions.
• Why clinical trials are an underused opportunity to learn about software behaviour—not just clinical outcomes.
• How observability can enable faster innovation while supporting patient safety and regulatory confidence.
• What the medical device industry can learn from the evolution of software-defined vehicles and modern embedded systems.
Watch the full video here.