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CAS-13485-CON · v1

ISO 13485 Consultant

ISO 13485:2016 + ISO 19011:2018

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Scope of certification (§8.2 a)

Consultant competence for ISO 13485:2016 Medical Devices Quality Management. Includes gap analysis, design, implementation guidance and pre-audit readiness.

Prerequisites (§8.2 e)

Tertiary education; 3+ years of relevant management-system implementation experience.

Equivalent training and experience from another provider are accepted (ISO/IEC 17024:2026 §5.2.3 d). CAS Academy training is not the only path.