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Commitment to Quality

Commitment to Quality

Trulife is committed to producing top quality products. Our sites in Sheffield in the UK, Dublin in Ireland and Bellingham in the USA are all certified with relevant ISO quality standards. (International Organisation for Standardisation)

Dublin, Ireland

The National Standards Association of Ireland (NSAI) is responsible for assessing a medical device manufacturer’s quality systems and it assess companies for ISO 13485:2016 – the relevant standard for medical devices. This is a globally accepted quality standard. The scope of our certificate includes the design, manufacture, distribution and customer support of breast prostheses, pressure relieving and positioning products and operating room theatre supports; the distribution of medical theatre/hospital equipment, walking and orthopaedic aids and accessories; the service of hospital equipment including patient treatment trolleys, stirrups, heat-sealers and warming cabinets.

Sheffield, UK

Trulife's UK manufacturing plant has had their quality systems tested and certified with ISO 13485:2016 by leading specialist Lloyds Register Quality Assurance (LRQA)

The scope of our certificate includes manufacture and sales of walking aids, orthoses , distribution of rehabilitation equipment.

Bellingham, USA

Trulife’s facility in Bellingham, our systems have been awarded both ISO 9001:2008 and the aerospace industry certification AS9100 Rev.C. Approved by Performance Review Institute (PRI). The certification covers a broad spectrum of activities typically implemented for aerospace and commercial requirements including full service design, manufacturing practices, CNC machining and assembly lines.

Our Quality Management system has been approved by Lloyds Register Quality Assurance (LRQA) to ISO 13485 standard. The scope of our certification in Bellingham includes the design, manufacture and related processes, and servicing of orthotic, orthopaedic and prosthetic products.

Conforming to European Standards

The CE marking on our products is our declaration as manufacturer that they comply with the essential requirements of the relevant European health, safety and environmental protection legislation.

The Medical Devices Directives outlines stringent rules to make sure that a medical device cannot jeopardize patient or user health and safety. The rules are designed to minimize or eliminate the risks associated with using a device, for anyone associated with its use. Only when products meet the required criteria can the CE Mark be applied. When Trulife applies the CE Mark, users can have absolute confidence that our products comply with all the necessary regulations.