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ISO 13485: Basic medical-device-quality checklist
ISO 13485: Basic medical-device-quality checklist
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Document control
Identify versions, approvers and points of use for critical instructions, forms and records.
Reference evidence: Document register, revision history and approvals
Traceability & batch records
Ensure batch records can link materials, operations, inspection and release decisions.
Reference evidence: Batch records, inspection forms and release records
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