Illustrative case — verify before publication
ISO 13485 · China

Certification audit of a Class IIb device manufacturer

Four-day certification assessment spanning QMS, risk management and device lifecycle evidence.

Duration4 days
LanguagesZH ↔ EN
Team2 specialists
IndustryMedical devices

The assignment

The assessment connected quality-system controls with design, risk and post-market evidence.

Approach

Preparation mapped core terminology across ISO 13485 procedures and risk-management records.

Publication note

Illustrative content only; replace with an approved CMS record before publication.

Illustrative outcome

Risk-management and QMS terminology remained consistent across the assessment.

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