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Complaint Form

Complaint Form

Description:
This Complaint form captures, evaluates, investigates, and closes complaints with traceable decisions and documented actions.

  • Record Awareness date and Complaint initiation date for timeline control.

  • Capture Device range involved and Traceability including UDI, model, and lot/serial.

  • Perform Complaint Evaluation (yes/no criteria) with written Justification.

  • Document Complaint Reporting to Authorities and link SOP-VIG-001 for Europe.

  • Record Complaint Investigation (DHF/DHR/DMR/QMS, testing) and conclusion.

  • Complete Risk Estimation against the Risk Management File and decide on CAPA.

  • Document Corrections and Response to the complainant with responsibilities and dates.

Your needs:

  • Medical device complaint form

  • Medical device complaint form for ISO 13485, MDR compliance.

  • Reduce rework, protect vigilance timelines, and strengthen audit readiness.

Use this form whenever a complaint is received to ensure intake, evaluation, investigation, and closure are consistently documented and traceable under EU complaint handling and vigilance expectations.

It consolidates the evidence trail. Awareness date anchors regulatory timelines; it matters because late escalation creates reporting risk. Traceability (UDI/lot/serial) links the issue to affected devices; it matters because it supports containment and trend review.

  • Capture complainant details and complaint description.

  • Record device identifiers and traceability fields.

  • Apply complaint criteria with justification and conclusion.

  • Assess reportability for Europe and attach vigilance decision records.

  • Plan and document investigation steps and outcomes.

  • Perform risk estimation and justify CAPA decisions.

  • Record corrections, communications, and closure approvals.

At Lexqara, we align complaint files with PMS workflows, CAPA linkage, and inspection-ready documentation—supported by training and practical templates. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. EU MDR (Regulation (EU) 2017/745) [https://eur-lex.europa.eu/eli/reg/2017/745/oj]. Download the template or request a short gap assessment.

Free

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