Managing the medical device directive. A practical case study.
Through a case study of a fictional company, this article provides a guide on how to implement CE-marking procedures, as detailed in the Medical Device Directive. The overlap in transitional periods between the Medical Device and Electromagnetic Compatibility Directives is discussed, together with issues such as selection of conformity assessment routes.
Nielsen
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Danish Medical Devices Certification, Hellerup, Denmark.
D004569:Electroencephalography / Q000295:instrumentation; D055590:Electromagnetic Phenomena; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards; D008389:Marketing of Health Services / Q000379:methods* / Q000639:trends; D008962:Models, Theoretical