Through selling to a global market we have dealt with the complexity of global regulatory requirements. We are an FDA registered organisation and have obtained FDA 510k approval for our own products and are fully conversant with the requirements to release products into specific markets.
Duckworth & Kent first obtained international certification of its Quality Management System in January 1996 under ISO 9001 and EN46001. At the same time it introduced CE marking of its medical devices under the Council Directive 93/42/EEC.
In addition, in 1998 Duckworth & Kent was assessed and certified to the requirements of ISO13485.
In September 2004 Duckworth & Kent’s Quality Management System was updated to conform to the requirements of ISO 9001:2000 and ISO13485:2003
Currently Duckworth & Kent are certified to ISO 9001:2015 and ISO 13485:2016 and are in conformance with the Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC.
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 received marketing or clincal approval. For further information about any investigational devices and their availiblity please contact us.