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Medical Device Biological Evaluation Report
We compile a comprehensive report that consolidates all data used to evaluate the biocompatibility…
Medical Device Biological Evaluation Report
We compile a comprehensive report that consolidates all data used to evaluate the biocompatibility…
- ISO 10993-1 - Biological evaluation of medical devices
- Meets the requirements of FDA/MDR
- Provides comprehensive ISO 10993 report
- Completed by in-house toxicologist (competent person)
ISO 10993-23 Test for Irritation
We offer ISO 10993-23 in vitro irritation testing to assess the irritation potential of…
ISO 10993-23 Test for Irritation
We offer ISO 10993-23 in vitro irritation testing to assess the irritation potential of…
- Good Laboratory Practice GLP study
- Biological Evaluation Plan and Report
- ISO 10993-23 - test for irritation - in vitro methods
Extractables & Leachables (E&L) Testing
We provide comprehensive Extractables & Leachables (E&L) testing to detect and measure substances released…
Extractables & Leachables (E&L) Testing
We provide comprehensive Extractables & Leachables (E&L) testing to detect and measure substances released…
- ISO 10993-18
- USP<1663>/<1664>,USP<665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Stufy Design
ISO 10993-5 Cytotoxicity testing
We offer ISO 10993-5 in vitro cytotoxicity tests under GLP conditions to assess biological…
ISO 10993-5 Cytotoxicity testing
We offer ISO 10993-5 in vitro cytotoxicity tests under GLP conditions to assess biological…
- Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-1 - cytotoxicity- in vitro methods
Medical Device Biocompatibility Testing
We provide testing services that assess cytotoxicity and evaluate biological risks associated with the…
Medical Device Biocompatibility Testing
We provide testing services that assess cytotoxicity and evaluate biological risks associated with the…
- Biological Evaluation Plan and Report
- In Vitro and InVivo methods
- Extractables and Leachables (E&L) Studies
- Also testing after cleaning, disinfection & Sterilization
Medical Device Biological Evaluation Plan
We conduct Biological Safety Evaluations in accordance with ISO 10993-1 to identify and assess…
Medical Device Biological Evaluation Plan
We conduct Biological Safety Evaluations in accordance with ISO 10993-1 to identify and assess…
- ISO 10993-1 - Biological evaluation of medical devices
- Meets the requirements of FDA/MDR
- Provides comprehensive ISO10993 testing plan
- Completed by in-house toxicologist (competent person)
