capa iso 13485

Complaint Management — Process Package (ISO 13485)

€69.00

SKU ISO-13 Category Tags , , , ,

ISO 13485 & MDSAP Ready

Editable Word & Excel

ISO 13485 / MDSAP / FDA QMSR

Used by 100+ quality teams

Process Package

Complete complaint management system covering ISO 13485 §8.2.2, EU MDR Art. 87-89, FDA QMSR §820.198, MDSAP Chapter 7. Reportability assessment integrated within complaint lifecycle (no separate template).

What’s included:

  • SOP-ISO-13 Complaint Management — intake, classification, investigation, resolution, post-resolution surveillance.
  • F-ISO-13.1 Complaint File (Word) — comprehensive complaint record with Section 5 Reportability Assessment integrated: 4-question framework (incident / device involvement / outcome / Art. 87(2)) + Art. 87(2) exclusion analysis with IFU and RMF cross-references.
  • F-ISO-13.2 Complaint and Customer Feedback Log (Excel) — the log of all complaints and customer feedback, one line per record; data source for the KPI dashboard and the Management Review.

Why this package: Complaints are the #1 source of vigilance events. This package gives you an end-to-end complaint system with reportability built into the workflow — auditor-tested approach.

Format: Microsoft Word | Excel (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase

€69.00

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Alessandro Stella

Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With 15+ years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.