Getting your IVD innovation to market…faster.

NAMSA is a leading contract research organization (CRO) and the world’s only Medical Research Organization (MRO) that assists In Vitro Diagnostics (IVD) manufacturers translate great ideas into great medical products.

From point-of-care diagnostics to instrument platforms to companion and complimentary devices, NAMSA provides global expertise for the full product development continuum. Through our regulatory consulting, laboratory testing and clinical research services, we consistently deliver proven time savings and cost efficiencies to clients around the world, resulting in hundreds of successful IVD regulatory submissions.

NAMSA also specializes in the 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. With over two dozen statisticians on staff, many of whom previously worked for the U.S. Food & Drug Administration (FDA), our biostatistics teams possess the knowledge to effectively model IVD studies and perform associated analyses to help manufacturers speedily and successfully introduce innovative products to the marketplace.

NAMSA’s 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.

NAMSA 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

To learn more about our regulatory, testing and clinical IVD and Companion Diagnostics services, please contact: