IVD & Companion Diagnostics

Getting your IVD innovation to market...faster.

From point-of-care diagnostics to instrument platforms to companion and complimentary devices, we provide global expertise for the full product development continuum, consistently delivering proven time savings and cost efficiencies to clients around the world, resulting in hundreds of successful IVD regulatory submissions.

We also work closely with partners to design and conduct of IVD trials by creating smaller, focused teams of IVD experts who customize data collection methods and monitoring plans to appropriately meet site, instrumentation and logistical requirements of each study. Our key partners include statisticians, many of whom previously worked for the U.S. Food & Drug Administration (FDA), biostatistics teams with the knowledge to effectively model IVD studies and perform associated analyses to help manufacturers speedily and successfully introduce innovative products to the marketplace.

IVD & Companion Diagnostics Expertise Includes:

Cardiac Biomarkers
Chemistry and Immunoassays
Diabetes Management
Hematology
Histocompatibility & Immunogenetics
Infectious Diseases
Molecular Diagnostics
Oncology
Therapeutic Drug Monitoring
Women's/Pre-Natal Care

For a full list of IVD device expertise, please click here.

Our experienced teams of experts deliver what you need, when you need it.

IVD Services Include:

Regulatory

Global Strategy & Submission
510(k)
CE Mark
BLA
PMA
IDE
Device Master File
Design Dossier/Technical File
CER

Clinical

Study Design & Implementation
Study Types: Feasibility, Pivotal, PMS/PMCF and Post-Market
Biostatistics/Data Analysis
Site Selection/Qualification
Database/Data Management
Clinical Audits

Quality Systems

Development Support
Gap Analysis
Quality Audits

Are Zi-Medical's services a good fit for your needs? Contact a representative through our site contact form.

IVD & Companion Diagnostics

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