FDA 510K Medical Device Biocompatibility Testing (Cytotoxicity, Sensitization and Irritation)
Project Description
MULTIPLE TESTING
FDA GMP Medical Device Product Safety Laboratory needed for biocompatibility testing (Cytotoxicity, sensitization and irritation testing of connected/digital blood pressure monitor to support FDA 510k and possible CF Mark.
At this stage we have determined the different components that will be in contact with the skin during its use and thanks to that we know that our device is of class A according to FDA (surface device in contact with intact skin, during less than 24 hours). Meaning that we will have to perform the 3 different tests on our device : Cytotoxicity, Sensitization and Irritation or Intracutaneous Reactivity tests.
Our product must meet ISO-10993-5 and 10993-10 standards in order to obtain FDA approval.
Project Information
Number:23-00262
Industry:Medical Devices
This request is closed and is no longer accepting quotes.
Register or Log In
to receive alerts when similar requests open in the future.
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
