Our Commitment to Quality

Conforming to International Standards

Trulife facilities in Dublin, Sheffield, Birmingham, Poulsbo and Bellingham, through 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 13485:2016 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: In our manufacturing facilities, our quality systems have been approved by Lloyd’s Register, and have been awarded with ISO 13485:2016 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 13485:2016 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.


Contact Our Team Today

Do you have a question about our products or services? Our dedicated staff is always here to help. Get in touch and we will revert to you as soon as possible. Thank you.

By continuing to use this site, you agree to the use of cookies. If you do not accept the use of cookies, simply exit the site. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.