Medical Device Toxicological Risk Assessment (TRA)
Project Description
Contract Research Organization needed to conduct medical device toxicological risk assessment (TRA) in accordance with ISO 10993-17:2002 and ISO/TS 21726:2019.
Could you please provide a formal quote and lead time of it?
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Please kindly note that the quote should apply the following.
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1) The sponsor has completed the chemical characterization test for a pool of lenses with different colors (tones) according to 10993-18: 2020. From the report, the following substances were detected and TRA for these substances needs to be conducted.
- Total 11 substances (Aluminum, boron, barium, calcium, potassium, magnesium, sodium, phosphorus, sulfur, silicon and chlorides) are detected.
- Only If possible, TRA for not identified compounds shall be performed.
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2) For product info, please refer to Product info and Instruction for use attached.
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If you have further questions, please let me know.
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Best regards,
Sanglok
Project Information
Number:21-01995
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 :
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- Specificity Testing
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- Medical Device ASTM Extractable Testing
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- Medical Device Bioburden Testing
- Total Aerobes Testing
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- Medical Device Biodegradation Subchronic Toxicity Studies Testing
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- 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
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- 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
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- Medical Device USP Polyethylene Container Testing
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- Medical Devices Analytical Chemistry Testing
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- - Gel Clot Testing
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- 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
