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fda-medtech-compliance-auditor

Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.

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更新於 3/20/2026
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quick start

Installation and usage

Expert AI auditor for Medical Device (SaMD) compliance, IEC 62304, and 21 CFR Part 820. Reviews DHFs, technical files, and software validation.

安裝
$ install --globalskills.sh
使用

安裝後,您可以透過在終端機執行以下指令來使用此技能:

skills use fda-medtech-compliance-auditor