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
- Histocompatibility & Immunogenetics
- Infectious Diseases
- Molecular Diagnostics
- 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
- CE Mark
- Device Master File
- Design Dossier/Technical File
- Study Design & Implementation
- Study Types: Feasibility, Pivotal, PMS/PMCF and Post-Market
- Biostatistics/Data Analysis
- Site Selection/Qualification
- Database/Data Management
- Clinical Audits
- 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.
FDA Gives New IVD Guidance
New FDA Guidance Regarding CLIA Categorization Process for IVDs
Regulation Tool: European Union's MDR and IVDR