Analytical Study Consulting for IVD

Analytical Study Consulting for IVD

We assist you in analytical and stability study design and evaluation according to the latest CLSI guidelines and relevant ISO standards, taking your intended purpose, product technology and sample characteristics into account.

Our Services

Analytical and stability study design for IVDs

Guidance for metrological traceability and cut-off establishment

Statistical analysis

Analytical performance report generation

How Can We Help You?

Rely on our expertise to conduct your clinical investigation successfully and efficiently. Contact us to learn more.

Alicja Ritz, PhD

Senior Expert IVD

Julie Tantau, AuD

Head of Clinical Operations

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