Transcription of (93/42/EEC) MEDICAL DEVICES DIRECTIVE
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(93/42/EEC) MEDICAL DEVICES DIRECTIVE
MEDICAL DEVICES DIRECTIVE (93/42/EEC) Try it for free on: Free of Charge application was designed to help manufacturers, consultants, notifiedbodies to keep under control the EU declaration of conformity. The application allows you to:Compose in few minutes declaration of conformity compliant with applicable directives;Search for a standard by keyword or synonyms or filtering by DIRECTIVE (s);Get the right standards form the list of harmonised standards ;Take under control list of products, declarations of conformity, amended declarationsof conformity;Download declaration in word or PDF format, with your logo;Store all declarations on a secure server;Receive an alert when an harmonized standards change in the official journal;Automatically provide report (action list), when an official journal changes;Allow to work with one or more separate manufacturers;Take under control product made by assembly of products;Allow multiple users to access to the same work with different roles(view/edit/approve) declaration of conformity.
European Pharmacopoeia monographs should be incorporated within the framework of this Directive; whereas, therefore, several European Pharmacopoeia monographs may be considered equal to the abovemen-tioned harmonized standards; Whereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules for the various phases of the …
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