title: Achieving the CE mark: getting it right first time.
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.
authors.affiliation: SGS Yarsley ICS Ltd, Weston-super-Mare, UK. sgsprodcert@sgsgroup.com
authors.forename: C
authors.initials: C
authors.lastname: Jepson
mesh_terms: 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