Elevate Program

Section Overview

• Benefits Provided by the Elevate Program
• Products Launched in the Elevate Program
  • ProClin™ Preservatives
  • Probumin^® BSA
• Quality Standards and Attributes
• Related Products

Elevate – Your raw materials partner in IVD manufacturing

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. 

IVD Audit-Readiness Benefits provided by the Elevate Program

• Verified process control for all products within the Elevate program
• Aligned with M-Clarity™ segments
• Audit access availability with experienced technical service, if requirements are met
• Audit-ready documentation (CoA, Dossier, IFU, etc.)
• Quick turnaround time in responding to inquiries and providing necessary documentation for manufacturer’s needs
• For additional benefits, see M-Clarity™ matrix

Elevate Dossier is available upon request

In the Dossier, you will be provided information on:

• Site Quality Survey self-assessment
• ISO 9001 certificate
• Product Specifications
• Declarations / Statements (animal origin content, latex content, BSE/TSE, phthalates, RoHS, etc.)

MQ300 Level or Higher Products Launched in the Elevate program

Upgrading our products to meet quality standards of MQ300 and above will raise the bar in support and services that we provide our customers.

You asked, Merck listened

The Elevate seal should assure you of product quality. Here’s the meaning behind the design:

1. Mountain ranges go from low to high showing our elevation in high quality products and services.
2. The check mark, in both the mountain range and negative space, represents the verification and scrutiny the products will go through to make sure the proper documentation and support is ready for customer audits/needs.
3. The three peaks indicate our ever-extending offering within the Elevate program

Quality standards and attributes for MQ300 Level and Higher materials in the Elevate program

RELATED PRODUCT RESOURCES

ProClin™ Biocidal Preservatives
For In Vitro Diagnostic Materials: Efficacy vs. Thimerosal and Sodium Azide
ProClin^™ Preservatives: Questions Addressing Regulatory Concerns
Probumin^® Bovine Serum Albumin (BSA)