With a team that includes technical and regulatory expertise, you can be confident your study will be planned and executed efficiently, and meet the high standards required for final clearance and approval through complex regulatory pathways (including 510(k), De Novo, PMA, and IVDR).

Whether you need a full-service CRO or just support for key study aspects, RQM+ can support your IVD clinical trials. At RQM+, we focus on partnership, collaboration, and quality at the highest level possible.

    medical devices

At RQM+, we believe there is no one-size fits all approach for IVD clinical trials. Each project is designed and executed to support our clients. We take a collaborative operational approach that is tailored to the intended use of the device, the envisioned markets, and the client's needs.

Our technical expertise and deep clinical trials backgrounds can support IVDs from any therapeutic area.

  • Infectious disease including bacteriology, virology, parasitology
  • Cancer detection, diagnosis, and monitoring
  • Precision medicine
  • Diabetes
  • Genetics
  • Microbiology
  • Hematology
  • Immunology
  • Transfusion and transplant
  • Women's Health
  • Others

RQM+ will consider the specific requirements and claims of the device when supporting study design. Study design considerations for certain IVDs:

  • Point-of-care (POC) tests / Near Patient tests (NPTs)
  • Over the Counter (OTC) tests / Self Tests
  • Companion Diagnostics (CDx)
  • Reagents, controls, instruments, specimen collection · Novel biomarkers
  • Interventional vs. observational studies
  • Patient recruitment versus banked samples
Rather than treating every IVD the same, RQM+ considers the unique aspects of the technology when conducting trials as this can inform site selection, data management, and other key trial aspects.
  • Molecular diagnostics including next generation sequencing (NGS)
  • IVD software including artificial intelligence
  • Instrumentation and associated software
  • Immunoassays including ELISA
  • Clinical chemistry
  • Flow cytometry
  • Microscopy
  • Mass spectrometry
  • Agglutination assays
  • Lateral flow assays
  • Novel technologies

We are passionate about your success. Tell us more about your needs so we can help.

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