Regulatory

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.

Certificates

We are committed to quality and the continuous improvement of products and Quality Management Systems to meet customer and global regulatory requirements.

The quality policy includes achieving customer satisfaction through good insight into our customer’s requirements as well as the evaluation of information relating to the customer perceptions as to whether Duckworth & Kent has met the customer requirements.

Certificates

ISO 13485:2016

CE (93/42/EEC) 2 Certificates

Duckworth & Kent Ltd. complies with international regulatory requirements and is certified for:

ISO-13485:2016
Medical Devices Directive 93/42/EEC
and is FDA registered

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.

Currently Duckworth & Kent is certified to ISO 13485:2016 and are in conformance with the Council Directive 93/42/EEC as amended by Council Directive 2007/47/EC.