Software Lifecycle
Manage the complete software development lifecycle for medical device software in compliance with IEC 62304. Track software requirements, architecture, implementation, testing, and maintenance activities with the rigor required for regulated software development.
Part of Software & Cybersecurity
Key Capabilities
What you get with the Software Lifecycle module.
How It Connects
Software Lifecycledoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.
Ready to see Software Lifecycle in action?
Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Software Lifecycle works within your specific compliance context.
More in Software & Cybersecurity
Explore other modules in the Software & Cybersecurity category.
Software Anomalies
Track and manage software anomalies including bugs, defects, and unexpected behaviors throughout the software lifecycle. Ensure all anomalies are properly documented, assessed for risk impact, and resolved with full traceability as required by IEC 62304.
Cybersecurity Assessment
Assess and manage cybersecurity risks for connected medical devices throughout their lifecycle. Document threat models, vulnerability assessments, and security controls as required by FDA cybersecurity guidance and EU MDR cybersecurity expectations.
OTA Update Management
Manage over-the-air software updates for connected medical devices with regulatory-compliant change assessment and deployment tracking. Ensure every software update is properly evaluated, validated, and deployed with full traceability and rollback capability documentation.