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Oxtex quality

Quality is an inherent part of our business process and we are committed to maintaining the effectiveness and continued improvement of our quality systems, products and services. Oxtex focuses on exceptional performance and applies the highest standards of quality.

Oxtex is certified to EN BS ISO 13485:2016 - Medical devices. Quality management systems. Requirements for regulatory purposes.

Our certified body is Lloyd's Register Quality Assurance Limited (LRQA). The scope of the Oxtex certification is the 'Design, development and manufacture of self-inflating hydrogel and silicone based medical devices'.

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What is tissue expansion?

A short explanation is available here.