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IEC 62304 defines the lifecycle process requirements for medical device software development, maintenance, risk management, and configuration management.

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50%
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Long-term
Relevance
10/12/2026
First Seen

Sources

Medical Imaging Software Development: 10 Key Questions for Choosing the Right Technology Partner

Related Entities

IEC 62304concept

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UnverifiedInternational standards IEC 61508 (functional safety) and ISO 13482 (safety of personal care robots) set explicit requirements for system failure probability and risk mitigation measures.70% similar

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