AI/ML Medical Device Documentation Kit – Complete Bundle
€499.00All 10 AI/ML documents + README + Master Index (Excel). One coordinated set, five markets. Save ~28% vs buying individually.
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All 10 AI/ML documents + README + Master Index (Excel). One coordinated set, five markets. Save ~28% vs buying individually.

Complete ISO 13485 QMS Documentation Kit — All 30 Process Packages + Quality Manual + Master Tracker. Aligned with ISO 13485:2016, EU MDR 2017/745, FDA QMSR, and MDSAP.
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Audit-ready documentation, at a welcome price
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