Medical Device File — 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 MDF (Medical Device File) management system covering ISO 13485 §4.2.3, EU MDR 2017/745 Annex II + III, 21 CFR 820.181 (DMR equivalence). Living document approach.
What’s included:
- SOP-ISO-17 Medical Device File — MDF structure, ownership, update triggers, NB submission cycle.
- F-ISO-17.1 Medical Device File Index (Word) — index aligned with EU MDR Annex II §1-6 (Device Description, IFU/Labels, Design and Manufacturing, GSPR Checklist, Benefit-Risk and RM, V&V) + Annex III (PMS Documentation). Cross-references to all other kit templates.
Why this package: MDF/TD is what NB and FDA inspect first. This package gives you a coherent index that ties together Risk Management, Clinical Evaluation, Usability, V&V, and PMS documentation.
Format: Microsoft Word (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.