“Analytical performance” refers to the ability of a product to correctly detect or measure a particular analyte. For this purpose, analytical performance studies must be carried out as a matter of course.
Biomex GmbH offers confirmation of the parameters listed in Annex I Paragraph 9.1 a) IVDR for your projects:
- Analytical sensitivity
- Analytical specificity
- Stability studies for assays and samples
- Trueness (distortion)
How can we help you to realize your projects? Contact us!