IEC 62304
Medical Device Software Life Cycle Processes
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IEC 62304 is the international standard defining the software development life-cycle processes for medical device software. It requires software to be assigned a safety class (A, B, or C) based on the severity of harm a software failure could cause, and scales the required development, documentation, and testing activities to that class.
Class A applies where no injury or damage to health is possible, class B where non-serious injury is possible, and class C where death or serious injury is possible. Higher classes require more detailed architecture, unit-level design, and verification, plus rigorous handling of software of unknown provenance (SOUP).
The standard covers development, maintenance, risk management (in conjunction with ISO 14971), configuration management, and problem resolution. It is a harmonized/recognized standard under both EU and FDA frameworks, making conformity a practical route to demonstrating software process control.
- —Safety classes A/B/C by severity of possible harm.
- —Higher class = more architecture, design, and verification rigor.
- —Requires managed handling of SOUP components.
- —Works alongside ISO 14971 risk management.
IEC 62304:2006/AMD1:2015 (safety classes and lifecycle processes); recognized under EU MDR and the FDA consensus-standards program.
Frequently asked questions
What does IEC 62304 stand for?
IEC 62304 stands for Medical Device Software Life Cycle Processes.
What is IEC 62304?
IEC 62304 is the international standard defining the software development life-cycle processes for medical device software. It requires software to be assigned a safety class (A, B, or C) based on the severity of harm a software failure could cause, and scales the required development, documentation, and testing activities to that class.
Which regulations cover IEC 62304?
IEC 62304:2006/AMD1:2015 (safety classes and lifecycle processes); recognized under EU MDR and the FDA consensus-standards program.