The non-BS QMS for software enabled medical devices

Most quality management systems were built for hardware, yet software products have unique needs: frequent design changes, cybersecurity, a large supplied stack and an entire development tool set tailored to these needs but not for medical devices. As such, what is optimal for hardware will not be optimal for software. This session provides ideas on how to Un-BS your Software QMS: Lean out your quality management system operationally. MedTech QMS strategist Ashkon Rasooli shares a practical framework for building a software QMS that is not just compliant, but also effective and efficient. From roadmap planning to release management and vulnerability monitoring. You'll learn how to: SW vs. Hardware: The QMS Differences SDLC Considerations: 62304, Agility, Design Change System Of Entry vs. System Of Record Evaluate an eQMS built for teams shipping continuously, not teams doing design freezes