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Parts & Sourcing

Replacement parts, supplier qualification, traceability, and compatibility evidence.

Parts & SourcingSep 15, 202616 min read

Replacement Parts After Repair: Compatibility Evidence and Remanufacturing Risk

How clinical engineering teams evaluate replacement parts under FDA's May 2024 remanufacturing guidance, QMSR 21 CFR 820, Figure 1, and CMS return-to-service rules.

By Ran Chen

Unbranded medical electronic circuit module on a slate-blue anti-static service mat beside an unlabeled closed specification folder and spare parts pouch.