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Polyflon gains ISO 13485:2016 accreditation

Polyflon ISO 13485We’re delighted to announce our eagerly anticipated accreditation to ISO 13485:2016, in association with BSI.

The certificate has been awarded to Polyflon for complying with the requirements of ISO 13485:2016 for the following scope; “the contract manufacture of non-sterile thermoformed polymer tube components for medical devices”.

Polyflon Medical Clean Room Facility

Polyflon Medical, a specialist medical tube component manufacturing cell within Polyflon Technology Ltd., focuses on custom-made thermoformed medical tube components for single use, minimally invasive medical devices, produced, inspected and packaged at our Staffordshire, UK site.

Polyflon’s Quality Manager, Leanne Stubbings comments on the accreditation; “We’re so pleased to have been awarded this certification and we feel that implementing this standard is vital in demonstrating our commitment to quality.”

Polyflon’s Director, Matthew Pedley, adds; “This accreditation marks a milestone in our medical component manufacturing operation, and is a great start to 2024. We’re looking forward to accelerated growth with many new opportunities ahead.

You can view our certification here, or click here to visit our Medical tubing component services.

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Give us a call on +44 (0)1785 859 054 or get in touch here to discuss your requirements.

Polyflon Medical Tube Components

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