COMPARATOR TESTING SERVICES
Comparator testing is a phase in the development of medical devices and diagnostics, involving the comparison of a new diagnostic product against a more established products (comparator). It demonstrates equivalency, superiority, or non-inferiority in terms of efficacy, accuracy, and usability and provides the data to support regulatory submissions, market positioning, and clinical adoption by illustrating how the new product stands compared to current standards and practices.
Comparator testing
Our Comparator Testing Services are designed to encompass all essential aspects of comparative analysis, ensuring a comprehensive evaluation of your diagnostic product. Here’s how we support these key components:
COMPARATOR SELECTION
Identifying appropriate established diagnostic products that serve as benchmarks for comparison.
COMPARATOR STUDY DESIGN
Delivering comprehensive reports that highlight the comparative performance of the diagnostic product, facilitating strategic market positioning.
SAMPLE COLLECTION & MANAGMENT
Coordinating the collection and handling of samples required for testing, maintaining integrity and compliance.
DATA ANALYSIS & INTERPRETATION
Employing advanced statistical methods to analyze test results, providing clear, insightful comparisons between products.
REGUALTORY DOCUMENTATION
Preparing detailed documentation of the comparator testing process and outcomes for regulatory submissions to FDA, IVDR, etc.
PERFORMANCE REPORTING
Delivering comprehensive reports that highlight the comparative performance of the diagnostic product, facilitating strategic market positioning.
COMPARATOR TESTING
At New Day , we combine our expertise in analytical validation with a commitment to quality, collaboration and innovation. As your end-to-end partner, we are dedicated to transforming your diagnostic innovations into reality from inception to commercialization, ensuring they are ready to make a meaningful impact on healthcare and patient lives.
Discover how our analytical validation services can accelerate the development of your diagnostic solutions. Contact us today and take the next step towards realizing your diagnostic breakthrough with us.