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PubMed · 10174198

Achieving the CE mark: getting it right first time.

C Jepson
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Abstract

Manufacturers are often unable to place the CE mark on all their medical devices immediately following an audit by a Notified Body because of deficiencies in documentation or procedures. In this article, the author uses the audit experience of a Notified Body to highlight some of the common problem areas. Manufacturers will be able to use this information as a checklist for their own system and significantly reduce the chance of delays in their CE-marking schedule.

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Consumer Product SafetyDocumentationEquipment and SuppliesGuideline AdherenceHumansIndustryQuality ControlUnited KingdomJournal Article

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C Jepson. 1997. Achieving the CE mark: getting it right first time.. https://pubmed.ncbi.nlm.nih.gov/10174198/

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