Trulife is committed to providing its customers with products and services of the highest quality. This is achieved through a process of continuous assessment and improvement to maintain customer satisfaction.Conforming to International Standards
Conforming to International Standards:
Trulife in Tallaght, Sheffield, Birmingham and Poulsbo, through enormous effort and commitment from all our staff has achieved ISO (International Standardisation Organisation) certification
The NSAI (National Standards Association of Ireland) applies ISO 13485:2003 Quality Management Systems to assess a medical device manufacturer’s quality systems in support of the medical device directives. This internationally recognised quality standard outlines particular quality management system requirements tailored to the manufacture of medical devices.
In our Poulsbo, Washington facility the Quality Management system has been approved by Lloyds Register Quality Assurance (LRQA) to ISO 13485:2003 standard. This certification includes the design process, the manufacturing and related processes and service of Orthotic, Orthopaedic and Prosthetic Products.
In the UK, our manufacturing plants in Sheffield and Birmingham have been approved by the Bureau Veritas and both have been awarded with ISO 13485:2003 certification
Conforming to European Standards:
The CE marking on our products is our declaration as manufacturer that our product complies 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 apply the CE Marking, which then allows the product to be freely placed on the market within the EU in compliance with the EU medical device directives.