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What is ISO 13485:2003?
ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.
Quality

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Quality Assurance is integral to Primasil operations. Our quality system is certified to ISO 9001:2000 and ISO 13485:2003 and is subject to regular internal and external audit.

Our team of dedicated, highly skilled quality engineers are responsible for verifying compliance and maintaining quality standards using precision measuring apparatus and the latest digital programmable measuring machines. All the equipment is regularly maintained and calibrated.

You need to be confident that the product you receive from Primasil will live up to your expectations.
From the initial enquiry, through to production of your product, Primasil has approved mechanisms in place to make sure that this happens.


Primasil Silicones Ltd., Kington Road , Weobley, Herefordshire, HR4 8QU, UK. tel: +44(0)1544 312600