Infrastructure and Equipment Control — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete infrastructure + equipment management system covering ISO 13485 §6.3 + 7.6, ISO 17025 (calibration), 21 CFR 820.72.
What’s included:
- SOP-ISO-21 Infrastructure and Equipment Control — equipment qualification, maintenance, calibration, OOT (out-of-tolerance) handling.
- F-ISO-21.1 Equipment Master List (Excel — 3 tabs) — auto-calc Days Until Cal with conditional formatting (green >30 / yellow 0-30 / red overdue), 6 sample equipment.
- F-ISO-21.2 Maintenance & Calibration Record (Word) — per-event record with OOT assessment matrix and product impact chain (NC → FSCA).
Why this package: Calibration overdue = audit finding. This package gives you a proactive calibration management system with built-in OOT response chain.
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 over 13 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.