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Throughout the years, the global regulatory bodies have been adding specifications and requirements that are more stringent on IVD Manufacturers. Many in vitro diagnostic devices, such as pregnancy tests, HIV tests, and COVID tests are seeing major regulatory compliance changes including important regional initiatives like the introduction of In Vitro Diagnostics Medical Devices Regulations (IVDR) in Europe. Manufacturers are trying to find the time and resources to keep up with the demand of more audit-ready documentation for their immunoassay test developments. IVD assay developers and manufacturers globally are navigating current and anticipating future regulatory changes by leveraging raw material suppliers that can not only provide high-quality products but also the expertise, quality systems, and documentation to support manufacturing needs.
Surmounting Regulatory Obstacles: Design-In Quality With The Elevate Quality Program
IVD manufacturers must demonstrate that the critical raw materials used to make their finished IVDs have equally strict quality and traceability standards. This means manufacturers will need to select raw materials with the appropriate quality standard, accurate supporting documentation, and technical assistance, as well as suppliers who will allow audits in their manufacturing facilities. Designing-in quality can reduce supply chain risk and save time and resources.
As a company that puts quality first, we have the expertise and the documentation to support assay developers’ needs for a raw material supplier that can provide high quality products to “design-in” quality. Our new Elevate Quality 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 any audit.
Why do we also call it a Quality Program? Because we’ve done our due diligence for quality documentation that exists to support these products. We worked with the manufacturing sites where these are made to ensure the documents are available and support any statements made in the dossiers for these products. The program makes it easier for our customers to quickly find the right products and documentation for their medical device/ IVD application.
The Elevate Quality Program supports customers globally and includes regular additions to the approved product list. To view the most current product list visit, SigmaAldrich.com/Elevate.
“The numerous benefits of the program include visibility of raw materials, enhanced change notification, verified process control, compliance declaration, and access to quality agreements,” explains Nathalie, adding: “As a bonus, no changes will occur in the specification of the material or part numbers for products under the program.” – Nathalie Barbier, IVD Development Specialist
As part of our high standards, the products invited to join the Elevate Quality Program will be verified by our M-Clarity™ Quality Program and hold an MQ300 quality level or higher. MQ300+ materials have guaranteed quality and documentation attributes as shown in the table below.
The Elevate Quality Program makes it easier for our customers to find all of the important links such as ISO9001 certificate, MFG Site self-quality assessment, shelf-life claims, product specifications, etc. through our newly created dossiers – which are only available for our Elevate products.
Elevate Quality Program Features
- Verified process control for all products within the Elevate program
- Enhanced change control including proper and timely change notifications
- Audit access availability with experienced technical service, if requirements are met
- Audit-ready documentations (CoA, Dossier, IFU, etc.)
- Quick turnaround time in responding to inquiries and providing necessary documentation for manufacturer’s needs
- Site regulatory and quality systems to ensure products reach expectations
- Resources to help in the audit and risk mitigation
- Growth to the program with new raw materials being added
- Site quality self-assessment is available
- Shelf life/expiration date is identified, if applicable
- Physical audits can be requested by the customer
- Products can be added to a quality agreement
- Customer notification is available for individual products as an opt-in
To learn more about the Elevate Quality Program, visit us at sigmaaldrich.com/elevate
