BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us

​Diagnostics

  • Help our clients develop, validate & register IVD devices under different classes
  • Assess market demand, barriers to entry, and device/technology competitiveness
  • Guide product target profile, risk analysis, and implementation of risk mitigation plans
  • Consult on technology proof-of-concept, validation/verification, qualifications (DQ, IQ, OQ, PQ), and overall quality management system
  • Advise on engagement with pharma/biotech and CRO for utilization of diagnostic devices in clinical trials or for CDx projects
Copyright ©2018 BIOMARKERS & DIAGNOSTICS CONSULTING, LLC
All Rights Reserved.
  • Home
  • FDA-Accredited 510(k) Review
  • Consulting Services
  • About Us
    • Our Track Record
    • Contact Us