Advisory Notice and FSCA — 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 FSCA system covering EU MDR Art. 89, MDCG 2024-1 (FSN format), 21 CFR 806, MDSAP Chapter 7. 5-tier categorization (Recall → Customer Notification).
What’s included:
- SOP-ISO-27 Advisory Notice and FSCA — triggering events, decision framework (severity × probability × scope), categorization, authority notification, communication, effectiveness verification.
- F-ISO-27.1 FSCA Decision Worksheet (Word) — per-event decision worksheet with 5-level severity + probability scales, 5-tier categorization, authority notification plan.
- F-ISO-27.2 Field Safety Notice (FSN) (Word) — aligned with MDCG 2024-1: subject, affected devices, hazard description, action required, manufacturer action, acknowledgement form, contacts.
Why this package: FSCAs are the highest-stakes events. This package gives you decision tooling + communication template aligned with MDCG 2024-1.
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.