IEC 62304 - Medical Device Software - Overview of the software life cycle processes

A simple, visual breakdown of a very not-simple standard: IEC 62304
IEC 62304 defines the software life cycle requirements for medical device software. To help navigate it, we created a high-level visual overview:
5 main processes : SW development; Risk Management; Maintenance & Change; Config. Management; Problem resolution
Software safety classes (A, B, C); this classification influences the level of documentation and testing needed.
Key normatives links; IEC 62304 is not isolated. It works alongside ISO 13485 (quality management systems) and ISO 14971 (risk management) and other many standards depending the complexity of your software / medical device.
And why traceability is critical; from requirements to tests and risk controls, traceability ensures full visibility across the software life cycle.
It doesn’t replace the text of the standard; but it gives software engineers and regulatory teams a fast visual to align on scope, steps, and strategy.
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