The Wise Way to Make Expert IVD Validation Smooth
CLSI-guided validation workflow platform designed for IVD companies
One Platform for the Entire Validation Lifecycle
IVDwise guides your team through the full CLSI Evaluation Protocol workflow, from experiment design and execution to statistical analysis, report generation, and final sign-off. Structured, CLSI EP-driven workflows help ensure every requirement is met consistently, without second-guessing or gaps.
Built for the Regulations That Govern Your Business
IVDwise automates statistical analysis, structures regulatory documentation, and standardizes validation procedures to meet leading IVD regulatory requirements, including EU IVDR (2017/746) and US FDA 21 CFR Part 809. Compliance is built into every step, not added at the end.
Expert Knowledge Embedded in Your Process
IVDwise was developed by a multidisciplinary team of academics, professional statisticians, and industry experts with decades of hands-on experience in IVD validation, advanced statistical modeling, and scientific software development. Their expertise is built directly into the platform’s logic, guardrails, and workflow design.
Less Time on Compliance, More Time on Innovation
When validation becomes guided and automated, scientists and R&D teams spend less time producing documentation and more time generating evidence, solving technical challenges, and advancing product development. IVDwise shortens timelines and helps differentiated products reach the market faster.
The Real Cost of Validation Is Not the Software
The cost of IVDwise is quickly offset by lower internal labor costs, faster study completion, fewer review cycles, and reduced risk of repeating experiments due to protocol or reporting errors.
* Based on a two-year model covering one CLSI workflow and three routine studies per year, IVDwise reduces labor costs by 47%.
Products
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
Generate compliant documentation with our AI-powered tool, which compiles, verifies, and organizes data from diverse sources into comprehensive reports, streamlining collaboration and ensuring regulatory accuracy.
Provide a thorough final review, pinpointing any areas that require attention for EU 2017/746 compliance, so you can submit your technical documentation with confidence.
A Team of Experts
Our software is developed by a dedicated team of professionals from both academia and industry, bringing together extensive expertise in statistics, regulatory compliance, and applied problem-solving.
With a deep understanding of real-world challenges, our team is uniquely equipped to bridge the gap between cutting-edge research and practical solutions for IVD manufacturers.
In addition to building the software, we offer on-demand consultancy services, combining our educational spirit with regulatory insight to help address your specific needs with precision and clarity.