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ISO 13485:2016 Quality Management System. Certificate MD 502905

The latest edition Quality Management System specifically for the Medical Device Industry. Demonstrates compliance to a recognised regulatory quality system.

ISO 13485:2016 Quality Management System (CMDCAS – Canada Certificate FM 56301

The latest edition Quality Management System specifically covering the Canadian Medical Devices Conformity Assessment System (CMDCAS). Demonstrates complianceto a recognised regulatory quality system.

EC Certificate

Our medical devices are CE marked to demonstrate compliance with the essential requirements of the Medical Device Directive 93/42 EEC, enabling our products to be legally marketed in the EU.