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Welcome at WQS Management consultants
Your partner for quality management, accreditation and certification in medicine and technology
On the following pages you will find information about attaining CE mark on medical devices and consumer goods, the implementation and maintenance of quality management systems according ISO 13485 and the Annex of Directive 93/42/EEC on medical devices or the Directive on In Vitro diagnostics 98/79/EEC, maintenance and creation of technical documentation, as well as the international registration of medical devices.
Top Informations (PDF documents)
Revision of the guideline 93/42, new requirements…
INTERPRETATIVE DOCUMENT OF THE COMMISSION'S SERVICES Guideline 2007/47
FDA approval of medical devices
