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White paper
A significant modification in the technology used in the manufacture of Tyvek® material will now require manufacturers of currently approved Tyvek®-based products to re-evaluate them for continued compliance with applicable standards and regulations. This white paper presents the details of the production transition regarding Tyvek®, and summarises the likely steps necessary to ensure the continued recognition of previously approved medical devices and packaging that incorporate Tyvek® material.
Related Services: Medical Device Regulation (MDR) | EU In Vitro Diagnostic Medical Device Regulation (IVDR) | Medical Device Single Audit Program (MDSAP)
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