Module21 April 20264 min read
Module spotlight: Software Lifecycle (IEC 62304)
Software in a medical device is held to its own standard. The software lifecycle module brings IEC 62304 processes — and the anomaly tracking that goes with them — into your QMS.
By MoniDoseQMS Team
Medical device software is not just code — it is a regulated component with its own lifecycle standard, IEC 62304. The software lifecycle module gives software teams a structured home for that lifecycle, from safety classification through development, maintenance, and anomaly resolution.
What you can do
- Manage the IEC 62304 software lifecycle processes
- Track software anomalies through to resolution
- Connect software work to design control and risk management
- Manage over-the-air updates under control
Why it matters
IEC 62304 is referenced by both EU MDR and the FDA for medical device software. Keeping the software lifecycle inside the QMS means software risk, anomalies, and changes stay connected to the device's overall design and risk files.