Ensure compliance in IVD product validation and verification with our software, designed to automate statistical analysis, customize regulatory reports, and standardize procedures to meet rigorous European IVD regulations
Reduce Regulatory Risk Early
Validation You Can Stand Behind – Every Time
Poorly designed studies, inconsistent documentation, and incomplete statistical evidence are common causes of regulatory delays. IVDwise reduces these risks by enforcing correct study design from the start and generating complete, compliant outputs automatically.
Automated Reporting
With CLSI protocols embedded in every experiment design, execution, and reporting step, your validation outputs are consistently structured, rigorously documented, and ready to withstand regulatory scrutiny. Audit-proof by design.
Your Regulatory Knowledge, Finally Under Control
Faster Validation. Fewer Mistakes.
Real Savings
IVDwise consolidates your organization’s validation knowledge, SOPs, and documentation into a single governed platform. Institutional expertise no longer walks out the door when staff turn over — it lives in the system, always up-to-date and accessible.
Standardized Procedures to Consolidate Company Expertise
IVDwise eliminates manual error-checking, redundant review cycles, and rework caused by poorly designed studies. Reporting is automated, documentation is always complete, and validation costs are predictable.
★ Customers have reported a reduction in revision rounds per development project.
Compliance with CLSI Guidelines
Our software is fully compliant with the latest CLSI guidelines, issuing warnings when datadeviates from the required standards. As regulations increasingly mandate the use of “state-of-the-art” practices, our software positions manufacturers ahead of the curve, ensuring future product submissions meet evolving standards.
EP06-ED2
Evaluation of the Linearity of Quantitative Measurement Procedures
EP07-ED3
Interference Testing in Clinical Chemistry
EP12-ED3
Evaluation of Qualitative, Binary Output Examination Performance
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement
EP24-A2
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves
EP25-AE
Evaluation of Stability of IVD Reagents
EP28-A3C
Defining, Establishing and Verifying Reference Intervals in the Clinical Laboratory
EP34-ED1
Establishing and Verifying and Extended Measuring Interval Through Specimen Dilution
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