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SAFE Service
Evaluation of Pesticide/ Medical Equipment Food/ Health Product
Pesticide Evaluation
• Qualitative identification and quantitative analysis of active ingredients and/or impurities of pesticides and their formulations
• Five batches analysis
• Physical and chemical properties
• Product quality control and quality analysis
• Residue analysis and stability determination
• Ecotoxicology studies
• Health Toxicological effect studies
Evaluation of Medical Equipment, Food and Health Product
• Cytotoxicity test, MEM extraction, MTT method, Indirect contact method, Direct contact method
• Irritant test, Skin irritation test, Mucosal irritation test, other irritant test
• Sensitization test, Maximum dose, Closed application
• Blood compatibility test, Hemolysis test, Complement activation test, Platelet adhesion and thrombosis test
• Biocompatibility test, Acute toxicity test, Subacute toxicity test, Subchronic toxicity test, Chronic toxicity test, Immunotoxicity, Reproductive toxicity, Genotoxicity, Carcinogenic toxicity, Pyrogen test, Implantation test
• Preparation of technical document for domestic and imported products registration
• Medical device registration
• Diagnostic reagent registration
• Clinical studies of type II and III medical devices
• Medical device material characterization data and assessment
• In vitro diagnostic reagent (IVD) clinical study
• Clinical trial design
• Clinical trial structure and investigator screening
• Ethics application and approval
• Clinical trials and audits
• Clinical trial project management and quality monitoring
• Clinical trial data management and statistical analysis
• Preparation of clinical trial reports
• Medical device biocompatibility evaluation
• Medical device material characterization data and assessment
• Post-implantation local response studies
• Qualitative and quantitative determination of metal and alloy degradation products
• Qualitative and quantitative degradation products of polymer medical devices
• Implement or exempt biological trials
• Medical device risk assessment

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