Change Control — 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 change control system covering ISO 13485 §7.3.9, EU MDR Art. 56(2), MDCG 2020-3 Rev.2 substantial change framework, and FDA QMSR §820.30(i).
What’s included:
- SOP-ISO-09 Change Control — 4-class internal classification (Class A/B/C/D), substantial change determination, NB notification triggers.
- F-ISO-09.1 Change Control Form (Word) — comprehensive form with 4-class classification + MDCG 2020-3 substantial change assessment matrix (9 questions), risk impact, implementation plan, post-implementation effectiveness.
Why this package: Change control under EU MDR is a high-risk audit area. This package implements MDCG 2020-3 Rev.2 directly into the workflow, eliminating ambiguity.
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.