Laboratory Testing Consultants for Medical/Pharmaceutical Products

Consulting services for lab testing of medical devices, pharmaceuticals, dietary supplements and other FDA regulated products.  Compliance testing may include Toxicity, In-Vitro Diagnostics (IVD/IVDD), IEC 60601-1 (Medical Electrical Equipment) and IEC 61000 (EMC/ Electromagnetic Compatibility) testing, Biological Safety and Biocompatibility,  CE, CSA and UL compliance testing, Sterilization Validation, alternative/traditional/botanical medicine and other medical, pharmaceutical and product testing.

Test-Related Consulting Services

Companies listed may include test process evaluation professionals, validation protocol specialists and general lab test consultants. Services may include:

  • US FDA compliance testing
  • Preparation for contact test labs
  • Medical product safety evaluations
  • In-Vitro Diagnostics, In-Vitro/In-Vivo Toxicology (IVD/IVDD)
  • Automated test and accelerated life tests
  • Studies and Trials – Animal studies and testing, pre-clinical trials, human clinical trials simulated clinical test and clinical test consulting
  • Biological: Analytical/Bioanalytical Tests, Biological Safety and Biocompatibility, Bioburden Studies (packaging qualification, etc.), Microbiology Testing and LAL Bacterial Endotoxin Testing
  • Chemistry and Toxicology Testing (Cytotoxicity, etc.)
  • International Standards
    • ANSI, AAMI, ISO11137-1994, ISO 17665-1:2006, ISO10933-1/-4 EN1174-3, ASTM Standards
    • ISO 10993 Biological Evaluation and Testing (Toxicity, Sensitization, etc.)
    • CE Mark, CSA, UL Compliance Testing (UL 544 compliance certification, etc.)
    • EMC, EMI and ETL Electrical Testing
    • IEC (International Electrotechnical Commission) 60601-1-1, -2, -4 Medical Electrical Equipment Safety and Electromagnetic Compatibility
    • IEC 61000-1 (-1, 2, 3, 4, 5 & 6) Electromagnetic Compatibility (EMC) Testing
    • Qualification, Certification, Registration and Regulatory Approvals
  • Sterilization – Sterilization Validation Testing – ETO Ethylene Oxide (gas), Irradiation/Gamma Radiation, Autoclave/Steam, E-Beam, Packaging Validation and Certificate of Sterility, Sterility Assurance Level (SAL), Particulates and Pyrogen Testing, Cleaning Validation
  • Test Related Documentation including SOPs, Procedures, Test Protocols, etc.
  • Quality Assurance Testing (QA/QC)
  • Manufacturing, processing, packaging and quality control methods and labeling
  • Clinical Research
  • Laboratory Consulting Services: Clinical Laboratory Improvement Amendments (CLIA). Good Laboratory Practices (GLP)
  • Medical Device Testing primarily in the following disciplines: Cardiology, Ophthalmology, Neurology, Urology Hematology, Orthopedics, Histology, Oncology and Immunology

Testing Laboratories listed may be located in Southern and Northern California (San Jose/San Francisco, Los Angeles/LA, Orange County and San Diego, CA) or elsewhere in the United States (US), Canada, Western Europe/EU (Germany, France, UK) and Asia (China, Japan and India).

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