Lifecycle Process Areas
IEC 62304 organises software development into defined process areas across Clauses 4–9. Click any card to expand its requirements. Use Level to switch between an overview and detailed clause-referenced content, and filter by safety class to focus on what applies to your software.
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Standards Integration
IEC 62304 in Context
IEC 62304 does not operate in isolation. It interfaces with a network of related standards covering risk management, usability, system-level safety, cybersecurity, and AI. Understanding these interfaces is essential for building a complete, compliant software lifecycle.
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The quiz covers both the IEC 62304 process areas and related standards. Introductory and Advanced question sets available — score 80% or higher to earn your certificate.