Quality

A Quality Company

Xiros operates under a strict quality management system which adheres to a number of international standards. In 1993 we were registered by the British Standards Institution (BSI) to ISO 9001, and in 1995 to EN 46001. This enabled us to become one of the first UK companies eligible to CE mark its products under the EU Medical Device Directive. In 2004 we gained accreditation to ISO 13485. In 2018 we superseded our ISO 9001 certification, whilst continuing to maintain our ISO 13485 certification.

In meeting these rigorous standards we consistently supply high quality products which meet the needs of our customers and clients, the surgeons who implant them and the patients whose quality of life is improved by receiving them.

To view and download our quality certificates, please click the links below:

ISO 13485 Certificate

CE Certificate

Our textile implants are manufactured in-house at our state-of-the-art factory premises in Leeds, UK. Each product is cleaned by specially developed processes before final preparation, inspection and packaging in our ISO 14644-1 Class 7 Clean Room. This facility is supported by our own in-house microbiological service. All of our implants are supplied within a double blister pack or double pouch pack to allow protection for the intended shelf life, and then sterilized by a validated gamma irradiation process.

We are dedicated to maintaining our excellent and long-standing reputation for quality and regulatory compliance. Throughout our history we have been successfully inspected by a number of important regulatory bodies including the FDA and BSI. We look forward to undergoing future audits and inspections, and continuing to prove ourselves as a company that doesn’t compromise when it comes to quality.