Conforming to International Standards
Trulife in Dublin, Sheffield, Birmingham, Poulsbo and Bellingham, through the enormous effort and commitment from all our staff, are certified to the ISO (International Organization for Standardization) standards for quality.
Dublin: The National Standards Association of Ireland (NSAI) applies ISO 13485:2003 Quality Management System to assess a medical device manufacturer’s quality systems in support of the medical device directives. This internationally recognized quality standard outlines particular quality management system requirements tailored to the manufacture of medical devices.
Sheffield and Birmingham: In both manufacturing facilities, our quality systems have been approved by the Bureau Veritas, and both have been awarded with ISO 13485:2003 certification.
Bellingham: We have achieved certification to both AS9100 Rev. C – the quality management system standards for the aerospace industry – and ISO 9001:2008. The scope of our certification includes full service design, manufacturing and precision CNC machining and assembly services for aerospace and commercial Industries.
Poulsbo: Our Quality Management system has been approved by Lloyds Register Quality Assurance (LRQA) to ISO 13485:2003 standard. The scope of our certification in Poulsbo 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 set out essential requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person and that any risks associated with the device are compatible with patient health and protection.
Medical Devices that conform to these requirements are entitled to application of the CE Mark, which then allows the product to be freely placed on the market within the EU in compliance with the EU medical device directives.