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
Revolutionize Your IVD Performance Studies
Automated Reporting
Our software streamlines the statistical analysis required for In Vitro Diagnostic (IVD) performance studies. Designed to deliver results fully compliant with CLSI guidelines, it ensures manufacturers meet the rigorous standards for regulatory approval. With our tool, you can ensure accuracy, compliance, and efficiency in every analysis, accelerating the process from study to submission.
Automated Reporting
Say goodbye to manual reporting. Our software automates the generation of comprehensive reports tailored for regulatory submission. It minimizes the risk of errors and eliminates the need for double-checking. By automatically compiling and formatting your performance study data, our tool simplifies one of the most time-consuming steps in the approval process, allowing you to focus on innovation and product development.
Customizable Reports, also for pre-validation
Standardized Procedures to Consolidate Company Expertise
Our software features customizable report templates designed for global regulatory bodies, including
FDA, health Canda and Japan. It ensures smooth submissions across multiple markets. It generates
pre-validation reports for non-compliant preliminary data, providing valuable insights early in the
development process to help you refine your studies before full submission.
Standardized Procedures to Consolidate Company Expertise
Our software enables the consolidation of your company’s know-how by standardizing
internal procedures. With well-documented processes that leave no room for
misinterpretation, you ensure consistency and efficiency across all teams. This streamlines
operations and preserves critical expertise within your organization, fostering better
collaboration and productivity.
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
EP17-A2
Evaluation of Detection Capability for Clinical Laboratory Measurement
EP25AE
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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