Management Review — 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, audit-ready management review system covering ISO 13485:2016 §5.6 and FDA QMSR §820.20. Includes 17 mandatory review inputs, output decisions framework, and integration with CAPA and KPI processes.
What’s included:
- SOP-CORE-02 Management Review — full SOP with frequency, agenda structure, input checklist (all 17 ISO §5.6 inputs), output requirements, action register management.
- F-CORE-02.1 Management Review Agenda + Minutes (Word) — combined template with cover, agenda, structured minutes per item, decisions/objectives, action register with status codes, 17-input checklist, sign-off, distribution list.
Why this package: Management review is one of the most-cited weaknesses in QMS audits. This package ensures you never miss an input and that your minutes survive the next audit.
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.