Validating Scientific Validity Reports to Support IVDR Compliance

Sysmex Corporation

Clinical

IVD

As part of their IVDR strategy, Sysmex Corporation partnered with Qarad, part of the QbD Group, to develop six Scientific Validity Reports for their XR-Series of hematology analyzers. The reports covered a wide range of analytes — white and red blood cells, hemoglobin, platelets, hematopoietic progenitor cells, and body fluids — and required deep scientific insight paired with strong regulatory know-how. Thanks to a structured and collaborative approach, Sysmex now has regulation-ready documentation to support a confident IVDR submission.

Challenge

Creating scientific validity documentation across six hematology analyte groups

To comply with the European In Vitro Diagnostic Regulation (IVDR) 2017/746, Sysmex needed to generate robust scientific validity documentation for the analytes measured by its XR-Series hematology analyzers.

This required a systematic approach: grouping analytes by type, defining their clinical relevance, and demonstrating their scientific validity using literature, expert consensus, and applicable guidelines.

With a broad and diverse scope — from red and white blood cells to platelets, progenitor cells, and body fluids — Sysmex turned to Qarad (part of the QbD Group) for support. Known for our experience in IVDR compliance and medical writing, we were trusted to lead the development of these essential reports.

Approach

A structured, collaborative strategy to build six Scientific Validity Reports

Qarad and Sysmex kicked off the project by aligning on the scope, grouping the analytes into six logical categories: white blood cells, red blood cells, hemoglobin, platelets, hematopoietic progenitor cells, and body fluids. This ensured each report would focus on clinically relevant conditions associated with each group.

Each report was developed by Qarad’s IVD medical writing team and followed a consistent structure:

A clear clinical overview of the analyte group
Summary of relevant scientific literature and clinical guidelines
Expert interpretation to support the analyte’s scientific validity

Throughout the process, Qarad maintained close collaboration with Sysmex—gathering feedback, refining content, and ensuring each report met internal review standards and IVDR expectations.

Result

IVDR-ready documentation to support confident submission

Together, Sysmex and Qarad successfully delivered six fully compliant Scientific Validity Reports. These reports now serve as a core part of the clinical evidence supporting Sysmex’s IVDR technical documentation for the XR-Series analyzers.

Beyond documentation, the project reinforced a trusted relationship that has been growing since 2018—positioning Qarad, part of the QbD Group, as a long-term partner in Sysmex’s regulatory and clinical strategy.

Validating Scientific Validity Reports to Support IVDR Compliance

Challenge

Approach

Result

Challenge

Creating scientific validity documentation across six hematology analyte groups

Approach

A structured, collaborative strategy to build six Scientific Validity Reports

Result

IVDR-ready documentation to support confident submission

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