:: We understand the importance of compliance ::
Through selling to a global market within our own business we have dealt with the complexity of global regulatory requirements. We have obtained FDA approval for our own products and are fully conversant with the requirements to release products into specific markets.

:: Quality Management System ::
Our Quality Management System is designed to allow easy integration into or in conjunction with our customer’s systems. We can assist start-up clients in putting together a quality system which is right for their business.

Duckworth & Kent first obtained certification of its Quality Management System In January 1996 under ISO 9001, EN46001 and ISO 13485.

In September 2004 Duckworth & Kent's Quality Management System was assessed and certified to the latest 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 & Kent also affixes CE marking to all its products according to Annex II of the Council Directive 93/42/EEC concerning Medical Devices. Duckworth & Kent is also FDA and MHRA registered.

Click below to view and download our certificates (pdf viewer required).
ISO 9001:2000	ISO 13485:2003	CE0120