Labelling and Translation Management — 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 labelling system covering EU MDR Annex I §23 (label content), ISO 15223-1:2021 (symbols), ISO 20417:2021 (general info requirements), Reg (EU) 207/2012 (e-IFU eligibility).
What’s included:
- SOP-ISO-31 Labelling and Translation Management — multi-language master, translation validation, e-IFU decision.
- F-ISO-31.1 Label / IFU / Translation (Word) — combined master: Master Label content (Annex I §23.2 + ISO 15223-1), Master IFU sections (§23.4), e-IFU eligibility per Reg 207/2012, multi-language translation validation with back-translation, approvals master + per-language.
Why this package: Label/IFU non-compliance is a market access blocker. This package consolidates content requirements + translation validation in a single auditable document.
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.