Trulife is committed to producing top quality products and our management team and staff have worked tirelessly to ensure our sites in Sheffield and Birmingham in the UK, Dublin in Ireland and Poulsbo and Bellingham in the USA are all certified with relevant ISO quality standards.
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.
Sheffield and Birmingham, UK
Trulifes’ two UK manufacturing plants have had their quality systems tested and certified with ISO 13485:2003 by leading specialist SGS.
At Trulife’s facility in Bellingham, our systems have been awarded both ISO 9001:2008 and the aerospace industry certification AS9100 Rev.C. 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.
Trulifes Quality Management System in place at Poulsbo has been tested by Lloyds Register Quality Assurance (LRQA) and approved to ISO 13485:2003 standard. This certification covers a number of elements including servicing of orthopaedic, orthotic and prosthetic products as well as designing and manufacturing of new products for the market.
The Medical Devices Directives outlines stringent rules to make sure that a medical device cannot jeopardise patient or user health and safety. The rules are designed to minimise 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.
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.
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