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).