Quality in Diagnostics Manufacturing


 Quality You Can Count On

Every in vitro diagnostic (IVD) manufacturer must ensure their suppliers provide products that are fit for purpose, from design and development through to the end-user. As such, IVD manufacturers operate in a regulatory environment that requires an enhanced level of support.

Are you ISO 13485 ready?

We are committed to providing reliable services for all your IVD manufacturing needs, complete with tailored quality and regulatory support. Our products come with clearly defined quality levels and recommendations for use, and all are accompanied by a corresponding level of service as well as supporting documentation:

  • Certificates of Analysis (COA)
  • Certificates of Origin (COO)
  • Specification sheets
  • Safety Data Sheets (SDS)
  • Additional technical product information

Additionally, IVD manufacturers are supported by our Enhanced Quality Program (EQP), which you can leverage to assist in your own risk assessment for the products you use, and to guide your process of choosing new raw materials. Defined quality levels enable you to easily compare the quality support and documentation available for raw materials you consider for use in your IVD assay.

The Elite Quality Grade

We developed the Elite Quality Grade to offer nearly all the GMP quality attributes without the associated cost burden. Feedback from IVD manufacturers indicates that the Elite grade is a good fit for critical raw material usage, balancing cost with the need for consistency, transparency and control.