IVD Clinical Performance

Analytical Performance Support

Depending on project scope, Bioexcel can support study planning, coordination and documentation for parameters such as:

HomeIVD Clinical PerformanceAnalytical Performance

Depending on project scope, Bioexcel can support study planning, coordination and documentation for parameters such as:

Analytical Performance Parameters
  • Limit of Detection
  • Limit of Quantitation
  • Precision
  • Repeatability
  • Reproducibility
  • Analytical sensitivity
  • Analytical specificity
  • Interference
  • Cross-reactivity
  • Linearity
  • Measuring range
  • Cut-off verification
  • Hook effect
  • Lot-to-lot variability
  • Specimen stability
HIPAA Compliant
ICH-GCP Compliant
FDA 21 CFR Part 11
ISO 9001
ISO 14155
ISO 27001 Certified
EU MDR 2017/745
EU IVDR 2017/746
US FDA Requirements
ISO 20916

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