Validation tpye / PART number

1.  Clinically application study
2.  Establishment  of intended use
3.   Scope utility: comparison to other methods 
4.   Validate Specificity claims  
5.  Initial Quality program/product application sheet construct 

1. Assay optimization plan 
2. Establishment of best practice. Pre-analytical, sample types, sample stability, sample rejection criteria 
3. instrument maintenance / critical operational elements identification 
4. identify reagent best practice; reagent source, stabilities 
5. Finalize Quality program/SOP 
6.  Estimation of margin of error (MU)

• Clinical verification 

              Reproducibility & Accuracy

• Clinical verification 

              Analytical Specificity - identify  interferences; i.e.  

              concurrent drugs

• Clinical verification 

              Est. Normal range  

• Quality  verification 

              Standard  operating manual construct. 

              Qualification and  validation document  written up for clinical

              sign off.

1.  Submit business plan for staffing and resources 
2. UKAS accreditation- (UK only)
3. Consideration of marketing and Commercialization (UKCA or CE marking processes).

Supporting evidence and publication to support change in intended use of assay or device 

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 Validation and data analysis of assay operational qualification requirements 

Report written to meet required regulator requirement (i.e. UKAS, FDA, CE marking, UKCA, IVDR)

Documentation write up and approval  

Identifying sample requirements as per verification plan and sourcing them for the study.

Conducting testing for customer and writing full report as required for ISO15189 requirements