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 ofa 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 GE-marking schedule.
Mots-clés Pascal : Fabricant, Appareillage, Génie biomédical, Assurance qualité, Certification, Conduite à tenir, Audit, Royaume Uni, Europe, Documentation, Traçabilité
Mots-clés Pascal anglais : Manufacturer, Instrumentation, Biomedical engineering, Quality assurance, Certification, Clinical management, Audit, United Kingdom, Europe, Documentation, Traceability
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 97-0471813
Code Inist : 002B30A05. Création : 03/02/1998.