iso14971-risk-matrixISO 14971 risk-management helper for medical devices. Score a risk with a reference 5x5 severity x probability matrix (with an optional residual-risk comparison), print the risk-control option hierarchy of ISO 14971:2019 7.1, and check whether a risk-management file covers the elements ISO 14971:2019 requires (4.4 plan, 4.5 file, 5 analysis, 6 evaluation, 7 control incl. 7.3/7.4, 8 overall residual risk, 9 review, 10 post-production).
Install via ClawdBot CLI:
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Usage Guide
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