Awarded for our life-saving Firesafe™ range – now mandatory in the UK and Germany.   

As well as annual quality and CE Marking audits by independent bodies, we are also regularly audited by our corporate customers.

CE Marking 0120 Medical Device Directive (MDD 93/42 EEC)

Regulatory approval is achieved by compiling a technical file for each product group, which is then reviewed by an independent expert.

Oxygen compatibility ISO15001: 2004 describes the steps for design, material selection, manufacturing and cleaning of products for oxygen use. We manufacture high-pressure oxygen products in our certified Class 100,000 clean room facility.

Application of Risk Management to Medical Devices EN14971: 2009 shows we have a documented risk management plan for our products.