Achieving the CE mark: getting it right first time.
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.
Jepson
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SGS Yarsley ICS Ltd, Weston-super-Mare, UK. sgsprodcert@sgsgroup.com
D003257:Consumer Product Safety; D004282:Documentation / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D007221:Industry; D011786:Quality Control; D006113:United Kingdom