BIOCOMPATIBILITY TESTS:
- Systemic Toxicity (ISO 10993-11)
- Irritation & Sensitization (ISO 10993-10 & USP)
- Implantation Testing (ISO 10993-6 & USP)
- Hemocompatibility Testing (ISO 10993-4)
- Reproductive & Developmental Toxicity (ISO 10993-3)
- Carcinogenicity Testing (ISO 10993-3)
- Pyrogenicity Testing (ISO 10993-11, IP, BP, USP)
- USP Plastics (USP Class I–VI)
- In-Vitro Cytotoxicity Testing (ISO 10993-5)
- In-Vitro & In-Vivo Genotoxicity Testing
- Sterility, Bioburden & Bacterial Endotoxin Testing
- Alternative to Animal Models
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Chemical Characterization (ISO 10993-18)
Comprehensive Biological and Toxicological Risk Assessment (ISO 10993-17)
CExtractables & Leachables Studies
Impurity / Degradant Toxicity Assessment |
Regulatory Documentation & Performance Testing
Biological Evaluation Plans (BEP) & Reports (BER)
Clinical Evaluation Reports (CER)Clinical Testing Support
Performance Testing of Devices
Package Testing (ISO 11607 compliance)
Electronic Safety Testing (EMI/EMC)
Risk Assessment & Compliance Support (ISO 14971) |
