생명과학 eQMS 14개 항목
Complaint Handling & MDR Reporting Checklist (21 CFR 820.198 / Part 803)
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Verifies complaint intake, evaluation, investigation, and Medical Device Reporting decisions and timelines. Use for complaint file review and post-market surveillance audits.
21 CFR 820.19821 CFR 803ISO 13485:2016 8.2
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Complaint Intake
- Is there a formally designated unit to receive, review, and evaluate complaints? *
- Is each complaint recorded in a complaint file with a unique identifier? *
- Record the date the complaint was received. *
Evaluation and Investigation
- Was the complaint evaluated to determine whether an investigation is necessary? *
- If no investigation was performed, is the reason and responsible person documented? *
- For complaints involving possible failure to meet specifications, was an investigation performed? *
MDR Reportability Decision
- Was the event evaluated against MDR reportability (death, serious injury, malfunction)? *
- Is the reportability decision and rationale documented? *
- Is a decision made whether the event is reportable within the required review timeframe? *
Reporting Timelines
- Were 30-day reports for reportable deaths/serious injuries/malfunctions submitted on time? *
- Were 5-day reports submitted where a remedial action is required to prevent unreasonable risk?
- Record the date the MDR was submitted to FDA (if applicable).
Documentation and Trending
- Does the complaint record capture device name, dates, investigation, and corrective action? *
- Are complaints trended and fed into CAPA and risk management? *
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