CBA Practice Questions - ASQ Certified Biomedical Auditor Exam

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A biomedical auditor discovers that a medical device manufacturer has been implementing changes to device design without updating the Design History File. Which FDA 21 CFR Part 820 section is most directly violated?

820.30 — Design Controls 820.40 — Document Controls 820.80 — Receiving, In-Process, and Finished Device Acceptance 820.100 — Corrective and Preventive Action

Correct Answer:

820.30 — Design Controls

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