Clinical In-Vitro Diagnostic Verification Testing (e.g., sample stability; kit shelf-life; System performance )
Project Description
BUDGET APPROVED ($500,000USD)
USA LABORATORY
MULTIPLE TESTING
MULTIPLE PRODUCTS
FDA GMP and CLSI Compliant Laboratory needed for in vitro diagnostic analytical verification testing [e.g., sample stability; kit shelf-life; System performance (particularly at low target levels and across the full test range), as applicable: precision (within-run, operator to operator, lot to lot of processing and test reagent and disposable components, day to day, total imprecision, instrument to instrument); reproducibility; dynamic and 'reportable' system range, linearity (high, medium, and low positive controls), analytical specificity, and definition of cutoff ratio / limit of detection; limit of blank (LoB; no template control); high-dose hook effect...]
Project Information
Number:21-00607
Industry:Medical Devices
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Other medical devices laboratory services.
Other Medical Devices testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :
- Biomaterials Testing
- of Tissues Testing
- Bone and Joint Computer Modeling Testing
- Ethylene Oxide Biological Indicators Performance Testing
- GHG Emissions Testing
- Implantable Medical Device Testing
- In-Vitro Diagnostic Testing
- Precision Testing
- Sensitivity Testing
- Specificity Testing
- Medical Device AATCC and ASTM Antimicrobial Testing
- Medical Device ASTM Extractable Testing
- Medical Device Barrier Testing
- Medical Device Bioburden Testing
- Total Aerobes Testing
- Total Coliforms Testing
- Total Fungi Testing
- Medical Device Biodegradation Subchronic Toxicity Studies Testing
- Medical Device Biomaterial Extracts Protein Assays Testing
- Medical Device Carcinogenicity Testing
- Medical Device Compliance Testing
- Medical Device Container/Closure Testing
- Medical Device Contamination Testing
- Medical Device Design and Modeling of Systems Medical Device Environmental Monitoring Testing
- Medical Device Ex-Vivo Hemocompatibility Studies Medical Device Finished Product Quality Control Testing
- Medical Device Genotoxicity Ames Testing
- Medical Device Genotoxicity Chromosomal Aberration Testing
- Medical Device Histopathology Testing
- Medical Device ISO 10993-1 (FDA GP 95-1) Biological Safety Testing
- Medical Device In-Vitro Biocompatibility Studies Testing
- Medical Device In-Vivo Biocompatibility Studies Medical Device In-Vivo Hemocompatibility Studies Testing
- Medical Device Irritation Studies Testing
- Medical Device Leachable Testing
- Medical Device Microbial Identifications Testing
- Medical Device Mutagenicity Testing
- Medical Device Particles Analysis Testing
- Medical Device Particulate Testing
- Medical Device Physical Testing
- Medical Device Preclinical Testing
- Medical Device Product Inoculations Testing
- Medical Device Product Safety Testing
- Medical Device Radiological Testing
- Medical Device Sensitization Testing
- Medical Device Shipping Validations and Shipping Testing
- Medical Devices Impact Resistance Testing
- Simulated Use Testing
- Medical Device Stability Studies Testing
- Medical Devices Accelerated Aging Stability Studies Medical Devices Real Time Stability Studies Medical Device Sterility Testing
- Medical Device Sterilization Dose Validation Medical Device Sterilization Validation Medical Device Tensile Testing
- Medical Device Thermal Analysis Testing
- Medical Device USP Implantation Studies Medical Device USP Microbial Limits Testing
- Medical Device USP and EP Plastics and Container Testing
- Medical Device USP Glass Container Testing
- Medical Device USP Polyethylene Container Testing
- Medical Device USP Testing
- AAMI Testing
- EP Bacteriostasis/Fungistasis Testing
- Medical Devices Analytical Chemistry Testing
- Medical Devices Bacterial Endotoxin Testing
- - Gel Clot Testing
- Medical Devices Bacterial Endotoxin Testing
- - Limulus Amebocyte Lysate LAL Testing
- Medical Devices Biomaterials Testing
- Medical Devices Biomechanical Platform Testing
- Medical Devices Biomechanical Testing
- Medical Devices Biomedical Testing
- Medical Devices Biomedical Testing
- Medical Devices Biophysical Characterization Testing
- Medical Devices Biophysical Properties Testing
- Medical Devices Biophysical Testing
- Medical Devices Cleaning Validation Testing
- Medical Devices Conformity Assessments Testing
- Medical Devices Cytotoxicity Testing
- Medical Devices Electrical Safety Testing
- Medical Devices Electromagnetic Compatibility Testing
- EMC Testing
- Medical Devices Ethylene Oxide Residuals Testing
- Medical Devices Failure Analysis Testing
- Medical Devices Fatigue Testing
- Medical Devices Fatigue Testing
- Medical Devices Foreign Materials Testing
- Medical Devices In-Vivo USP Testing
- JP Testing
- EP Pyrogen Testing
- Medical Devices Leak Testing
- Medical Devices Materials Characterization Testing
- Medical Devices Methods Development and Validation Testing
- Medical Devices Microbiology Testing
- Medical Devices Packaging Studies and Testing
- Medical Device Package Integrity Testing
- Medical Device Packaging Burst Testing
- Medical Device Packaging Creep Testing
- Medical Device Packaging Dye Penetration Testing
- Medical Device Packaging Peel Testing
- Medical Device Packaging Vacuum Leak Testing
- Medical Devices Safety Evaluations Testing
- Medical Devices Toxicology Testing
- Medical Devices Transportation Simulation Testing
- Medical Devices Vibration Testing
- Medical Products Re-engineering Testing
- Medical Products Reverse Engineering Testing
- Reusable Device Studies Testing
- Reusable Medical Devices Testing
- RoHS Testing
- Steam Biological Indicators Performance Testing
- USP Purified Water Testing
- USP Water for Injection Testing
- WEEE Testing
