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Services >> Regulatory
Duckworth & Kent first obtained certification of its Quality Management System In January 1996 under ISO 9001, EN46001 and ISO 13485.
In September 2004 Duckworth and Kent's Quality Management System was assessed and certified to the latests standards, ISO 9001:2000 and ISO13485:2003 covering the following scope of activities:
The design, manufacture, supply and repair of non sterile precision reusable surgical instruments. Subcontract machining of implantable titanium items. Subcontract assembly of electrical surgical instruments.
Duckworth and Kent also affixes CE marking to all its products according to Annex II of the Council Directive 93/42/EEC concerning Medical Devices.
Within Duckworth & Kent's product range are devices that are classed as 'Investigational Devices'. These devices may not be available for sale in certain countries where the product has not yet recieved marketing or clincal approval. For further information about any investigational devices and their availiblity please contact us
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