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Quality Systems

	ISO 13485: 2003 Quality Systems for Medical Device Manufacturers Design, manufacture of medical devices for respiratory therapy, infant care and pain relief
	ISO15001: 2004 Oxygen Compatability Describes the steps required for design, material selection, manufacturing and cleaning of products for oxygen use.
	EN14971: 2001 Risk Analysis for Medical Devices We have documented a risk analysis for every product group within the Carnét range and these are regularly reviewed as our experience grows.
	CE Marking Medical Device Directive (MDD 93/42 EEC) - we compile a Technical File for each product group and this is reviewed by an independent technical expert sent by our Notified Body, GMed LNE. The basis for regulatory approval, referred to as Annex II under the Directive, is the compilation and review of a Technical File in combination with an approved quality system standard for ongoing manufacturing
	Third Party Audits In addition to annual quality and CE Marking audits from our Notified Body we are regularly audited by our corporate customers including GE Healthcare, BOC and Air Products.
	Investors In People The Investors In People award is an internationally recognised management system that drives the development of an organisation through the development of the people working within it.