V5 Ultimate
Compliance

IEC 62304

Medical device software — Software life cycle processes

TL;DR

International standard for medical device software lifecycle — required for software in a device (SiMD) and software as a medical device (SaMD).

IEC 62304:2006/AMD 1:2015 (with AMD 2 in late preparation) defines the lifecycle processes for medical-device software: development planning, requirements, architectural and detailed design, unit/integration/system testing, release, problem resolution, change control and configuration management. Activities scale with the software safety class — A (no injury possible), B (non-serious injury), C (death or serious injury).

For SOUP (Software Of Unknown Provenance — operating systems, open-source libraries) the standard demands documented requirements, anomaly evaluation and a change-monitoring plan — the most common 62304 gap in MedTech audits.

Regulatory anchors
  • IEC 62304:2006/AMD 1:2015
  • FDA Guidance: Device Software Functions (2023)
How V5 handles it
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
ISO 14971ISO 13485Design controlsDesign verificationCSVGAMP 521 CFR 82021 CFR 803FDA QMSRIEC 62366ISO 10993IEC 60601510(k)PMADe NovoEU MDRIVDRMDSAPNotified BodyPredicate device
Want to see IEC 62304 in V5?

Free trial, no credit card, onboard in days, not months.

Start freeBook a demo
Back to glossary