Document and Record 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
A complete, audit-ready document control system covering all requirements of ISO 13485:2016 §4.2.4-4.2.5, FDA QMSR (21 CFR 820.40), and 21 CFR Part 11 for electronic records.
What’s included:
- SOP-CORE-01 Document and Record Control — full SOP with control page, lifecycle workflow, retention table, KPIs, 5 annexes including complete document hierarchy reference.
- F-CORE-01.1 Document Master List (Excel) — single authoritative index of all controlled QMS documents with conditional formatting on review dates and status dropdowns.
- F-CORE-01.2 Document Change Request Form (Word) — DCO workflow from request through approval.
- F-CORE-01.3 Record Destruction Authorization (Word) — with Legal Hold check and retention verification.
Why this package: Document control is the foundation of any QMS audit. This package gives you a system that survives ISO 13485 surveillance audits, FDA inspections, and MDSAP audits without rework.
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
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.