Polyflon gains ISO 13485:2016 accreditation

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

This accreditation is specifically focused towards the medical tube component manufacturing cell of the company; Polyflon Medical, which specialises in custom-made thermoformed medical tube components for single use, minimally invasive medical devices, produced, inspected and packaged at our Staffordshire, UK site.

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’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 certificate here.

Find out more about Polyflon Medical at our dedicated medical website > www.polyflonmedical.co.uk.

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