Clinical Evaluation — 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 clinical evaluation system covering EU MDR Art. 61 + Annex XIV Part A, MDCG 2020-5 (equivalence), MDCG 2020-13 (CEAR template), MDCG 2020-7/8 (PMCF).
What’s included:
- SOP-ISO-10 Clinical Evaluation — 3-pathway approach (Own investigation / Equivalence / Literature), evaluation cycle, PMCF integration.
- F-ISO-10.1 Clinical Evaluation Plan (CEP) (Word) — pre-evaluation plan with MDCG 2020-5 equivalence 3-pillar (technical + biological + clinical), GSPR mapping, search strategy.
- F-ISO-10.2 Clinical Evaluation Report (CER) (Word) — output report aligned with MDCG 2020-13 CEAR structure.
Why this package: Clinical evaluation is the #1 challenge for EU MDR-CE marking. This package gives you both planning and reporting templates aligned with NB expectations.
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.