The ever-changing diagnostics regulatory requirements are becoming more stringent, as in the introduction of IVDR in the European Union. IVD assay developers and manufacturers globally are anticipating future regulatory changes by leveraging raw material suppliers that can not only provide high-quality products but also the expertise and documentation to support manufacturing needs. Our new Elevate program gives IVD manufacturers the confidence needed to enter a more stringently regulated landscape with products that meet the high standards including documentation that will suffice for audit-readiness. The Elevate program supports customers globally and includes regular additions to the approved product list. Products that are chosen to participate in the program will have an MQ segment of 300 or higher along with enhanced quality and documentation attributes as shown in the table below.
In the Dossier, you will be provided information on:
Upgrading our products to meet quality standards of MQ300 and above will raise the bar in support and services that we provide our customers.
The Elevate seal should assure you of product quality. Here’s the meaning behind the design:
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