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CE MDR

[CE] IVD CE 적합성 평가 절차

IVD의 Directive에서 CE 적합성 평가 절차는 다음과 같다.

Annex III : EC Declaration of Conformity (자가적합선언)

Annex IV : Full Quality Assurance System (전제품질보증시스템)

Annex V : EC Type Examination (EC 형식 시험)

Annex VI : EC Verification (EC 검증)

Annex VII : Production Quality Assurance (생산 품질 보증)

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Company : ICMC (International Certification Management Center Co., Ltd.)
CEO : Bong Ju Kim
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