Analytical Performance for FDA/CE submissions, and OQC/ IQC

At ZP we have built Djuli to be inline with Clinical and Laboratory Standards Institute standards: EP06-A, EP05-A3, EP07, EP12-A2. EP-A3. EP17-A2, EP19, EP25-A...

 

EP06-A focuses on determining the linearity of a diagnostic, whilst EP05-A3 can be used to determine precision, including manufacturing precision/repeatability/reproducibility.  In this video we show how Djuli can be used to determine linearity inline with EP06-A, and how data can be compared within Djuli in order to address EP05-A3.

 

As part of ZP's ISO13485 contract manufacturing of invitro diagnostics we use Djuli to batch release IVDs as part of our out-going-quality-control (OQC), and so have validated Djuli's stats algorithms.


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