IEC 62304 Medical Device Software

Apply IEC 62304 (Medical device software — Software lifecycle processes) to AI in medical-device software. Learn the safety classification (Class A, B, C based on hazard severity), the software development lifecycle, configuration and problem-resolution processes, the maintenance process, and the expectations of Amendment 1 (and the upcoming Edition 2) for AI in medical software.

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Lessons in This Topic

Work through these 6 lessons in order, or jump to whichever is most relevant to your matter.

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IEC 62304 Overview

Intermediate
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Safety Classification A, B, C

Advanced
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Software Lifecycle Processes

Advanced
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Configuration & Problem Resolution

Advanced
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AI Software Expectations

Advanced
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IEC 62304 Evidence Pack

Advanced