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  • Writer's pictureMatrix Plastics Ltd

Matrix Medical Plastics is ISO 13485:2016 certified.

We're thrilled to announce that as of November 2023, Matrix Plastics Ltd T/A Matrix Medical Plastics has been found to conform with an appropriate and effective management system that meets the requirements of ISO 13485:2016.

ISO 13485:2016 is the international standard which specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

"We know that quality and compliance is imperative when manufacturing medical devices, and so securing this ISO certification is a fantastic achievement for our medical compounding business," says Nigel Batt of Matrix Plastics. "In addition to this new certification we have gained, we're proud to add to our medical compounding quality standards by ensuring that all medical products are processed and tested according to ISO Class 9 cleanroom regulations and all ingredients used on site in the production of medical products meet the requirements of ISO 10993-1:2018 and USP Class VI."

Matrix Medical Plastics is the UK's first 'cleanroom' plastic compounding facility with a sterile manufacturing environment and impeccable hygiene standards, making us the medical compounding partner of choice for many manufacturers and OEMs across Europe.

Well done to everyone at Matrix who was involved in helping us achieve this new certification.

You can view and download our ISO 13485:2016 certificate here:

Download PDF • 407KB



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