Risk 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 risk management system aligned with ISO 14971:2019/A11:2021 and IEC 62366-1:2015 for use-related risk. Includes ALARP framework, hazard library starter, and integration with Design Control and PMS.
What’s included:
- SOP-ISO-02 Risk Management — full SOP with severity/probability scales, ALARP, hazard identification methods, control hierarchy.
- F-ISO-02.1 Risk Management Plan (Word) — per-device family RM Plan template.
- F-ISO-02.2 Risk Management Report (Word) — output of RM cycle with benefit-risk analysis.
- F-ISO-02.3 Risk Analysis Matrix (Excel — 4 tabs) — auto-calc RPN formulas, conditional formatting green/yellow/red, hazard library starter.
- F-ISO-02.4 URRA (Excel — 3 tabs) — Use-Related Risk Analysis per IEC 62366-1, 62 formulas, critical task auto-flag.
Why this package: Risk Management is the core of medical device QMS. This package gives you the complete RMF (Risk Management File) infrastructure expected by NBs and FDA.
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.