IEC 62304

Lifecycle requirements for medical device software.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

IEC 62304:2006 (with Amendment 1:2015) defines the lifecycle requirements for medical device software, including software development planning, requirements analysis, architectural design, implementation, integration, testing, release, and maintenance - scaled by software safety classification (Class A, B, C).

What this means in practice

IEC 62304 is a recognized consensus standard by FDA and a harmonized standard under EU MDR. It is foundational for SaMD and software-containing devices.

Use cases

1 scenario

Legacy infusion pump firmware refresh

Software lead

A team refactoring 10-year-old C firmware classifies the safety class as C, retrofits a software development plan, traces requirements to unit tests, and documents SOUP for the RTOS and TCP/IP stack.

OutcomeThe refresh ships with full IEC 62304 evidence, satisfying both 510(k) reviewers and an EU MDR notified body.

Cross-references

Governs

Things this term applies rules or requirements to.

Uses

Concepts or artefacts this term builds on.

Primary references

3 sources

Link health: 3 verified· last checked 2026-05-09

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