Diagnostic Medical Device

Our device program serves the United States, Pacific Rim Nations, Canada, Europe, and Latin America providing contract laboratory testing of medical and diagnostic devices.  Our testing program is innovative and unique.  Collaborations with facilities located in San Francisco, San Diego and Los Angeles give Biometrix clients access to the most technologically advanced testing centers available.  Our investigators possess a wealth of knowledge in GCP, GLP & GMP testing standards and are ready to provide you with the high quality and personalized service you desire.

Biometrix will pilot your product development from the concept phase through regulatory submissions. We have the qualifications and experience needed to represent your interests at regulatory agencies worldwide.  We offer a full spectrum of services to diagnostic medical manufacturers; including clinical testing, laboratory services, regulatory submission assistance and strategic consultation.

Product evaluation services include:

  • BIOCOMPATIBILITY
  • BIOEQUIVALENCE
  • EFFICACY
  • SAFETY
    • IRRITATION
    • INTRACUTANEOUS REACTIVITY
    • SENSITIZATION

Biometrix is dedicated to finding the most efficient and effective ways to test and register your diagnostic medical device products.  We are happy to offer our clients measurements in the following categories:

  • EXTERNAL COMMUNICATING
    • BLOOD PATH/INDIRECT
    • CIRCULATING BLOOD
    • TISSUE/BONE/DENTIN
  • NEEDLES & INJECTION DEVICES
    • CHOLESTEROL
    • DIABETES GLUCOSE
    • TISSUE/BONE/DENTIN
  • SURFACE DEVICE
    • COMPROMISED MEASURES
    • INTACT MEASURES
    • MUCOSAL MEMBRANE MEASURES
  • MONITOR MEASUREMENTSGet your medical devices tested now; contact Biometrix!