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Biocompatibility testing
Irritation Testing (ISO 10993-23)
Carcinogenicity Testing (ISO 10993-3)
Cytotoxicity Testing (ISO 10993-5)
Degradation Testing (ISO 10993-9)
Genotoxicity Testing (ISO 10993-3 & ISO 10993-33)
Hemocompatibility Testing (ISO 10993-4)
Implantation Testing (ISO 10993-6)
Extractables & Leachables
Chemical Degradation Studies: Assessing Long-Term Stability
FT-IR Spectroscopy: Chemical Composition and Material Identification
Targeted Analysis: Extractables & Leachables (ISO 10993-18)
Total Organic Carbon (TOC) Analysis: Aqueous Extract Evaluation
Toxicological Risk Assessment (ISO 10993-17): Biological Safety Evaluation
UV-VIS Spectroscopy: Characterization and Quantitative Analysis
Medical Device Consulting Services
Medical Device Development & Manufacturing Support
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Microbiology & Sterility Testing
Bacterial Endotoxin Testing (LAL Test)
Bacteriostasis & Fungostasis (B&F) Testing
Bioburden Validation (ISO 11737-1 & USP <61>)
Bioburden Testing (ISO 11737-1 & USP <61>)
Product Sterility Testing (USP <71>)
Bep Ber
Biological Evaluation Plan (BEP) – ISO 10993-1
Biological Evaluation Report (BER) – ISO 10993-1
Consulting
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Medical Device Consulting Services
Global Medical Device Consulting
Other
Accelerated Aging Testing (ASTM F1980)
EO & ECH Residual Testing (ISO 10993-7)
In Vitro Skin Absorption and Dermal Penetration Testing
ISO 11607 Package Validation
Reprocessing Validation for Reusable Medical Devices
USP Biological Reactivity Testing (Class I–VI)
USP <87> Cytotoxicity Testing
USP <88> In Vivo Biological Reactivity Testing
Solutions
For Consultants Companies
For Start-ups
For Medical Device Manufacturers
For Notified Bodies/FDA
Quality
Resources
MedTech Knowledge Hub
Biocompatibility FAQ
About US
Team
Mission Vision History
Careers at EBI
News
Offer
Biocompatibility testing
Irritation Testing (ISO 10993-23)
Carcinogenicity Testing (ISO 10993-3)
Cytotoxicity Testing (ISO 10993-5)
Degradation Testing (ISO 10993-9)
Genotoxicity Testing (ISO 10993-3 & ISO 10993-33)
Hemocompatibility Testing (ISO 10993-4)
Implantation Testing (ISO 10993-6)
Extractables & Leachables
Chemical Degradation Studies: Assessing Long-Term Stability
FT-IR Spectroscopy: Chemical Composition and Material Identification
Targeted Analysis: Extractables & Leachables (ISO 10993-18)
Total Organic Carbon (TOC) Analysis: Aqueous Extract Evaluation
Toxicological Risk Assessment (ISO 10993-17): Biological Safety Evaluation
UV-VIS Spectroscopy: Characterization and Quantitative Analysis
Medical Device Consulting Services
Medical Device Development & Manufacturing Support
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Microbiology & Sterility Testing
Bacterial Endotoxin Testing (LAL Test)
Bacteriostasis & Fungostasis (B&F) Testing
Bioburden Validation (ISO 11737-1 & USP <61>)
Bioburden Testing (ISO 11737-1 & USP <61>)
Product Sterility Testing (USP <71>)
Bep Ber
Biological Evaluation Plan (BEP) – ISO 10993-1
Biological Evaluation Report (BER) – ISO 10993-1
Consulting
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Medical Device Consulting Services
Global Medical Device Consulting
Other
Accelerated Aging Testing (ASTM F1980)
EO & ECH Residual Testing (ISO 10993-7)
In Vitro Skin Absorption and Dermal Penetration Testing
ISO 11607 Package Validation
Reprocessing Validation for Reusable Medical Devices
USP Biological Reactivity Testing (Class I–VI)
USP <87> Cytotoxicity Testing
USP <88> In Vivo Biological Reactivity Testing
Solutions
For Consultants Companies
For Start-ups
For Medical Device Manufacturers
For Notified Bodies/FDA
Quality
Resources
MedTech Knowledge Hub
Biocompatibility FAQ
About US
Team
Mission Vision History
Careers at EBI
News
contact
Offer
Biocompatibility testing
Irritation Testing (ISO 10993-23)
Carcinogenicity Testing (ISO 10993-3)
Cytotoxicity Testing (ISO 10993-5)
Degradation Testing (ISO 10993-9)
Genotoxicity Testing (ISO 10993-3 & ISO 10993-33)
Hemocompatibility Testing (ISO 10993-4)
Implantation Testing (ISO 10993-6)
Extractables & Leachables
Chemical Degradation Studies: Assessing Long-Term Stability
FT-IR Spectroscopy: Chemical Composition and Material Identification
Targeted Analysis: Extractables & Leachables (ISO 10993-18)
Total Organic Carbon (TOC) Analysis: Aqueous Extract Evaluation
Toxicological Risk Assessment (ISO 10993-17): Biological Safety Evaluation
UV-VIS Spectroscopy: Characterization and Quantitative Analysis
Medical Device Consulting Services
Medical Device Development & Manufacturing Support
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Microbiology & Sterility Testing
Bacterial Endotoxin Testing (LAL Test)
Bacteriostasis & Fungostasis (B&F) Testing
Bioburden Validation (ISO 11737-1 & USP <61>)
Bioburden Testing (ISO 11737-1 & USP <61>)
Product Sterility Testing (USP <71>)
Bep Ber
Biological Evaluation Plan (BEP) – ISO 10993-1
Biological Evaluation Report (BER) – ISO 10993-1
Consulting
EU MDR Consulting Services
FDA Regulatory Consulting
Global Medical Device Consulting
Medical Device Consulting Services
Global Medical Device Consulting
Other
Accelerated Aging Testing (ASTM F1980)
EO & ECH Residual Testing (ISO 10993-7)
In Vitro Skin Absorption and Dermal Penetration Testing
ISO 11607 Package Validation
Reprocessing Validation for Reusable Medical Devices
USP Biological Reactivity Testing (Class I–VI)
USP <87> Cytotoxicity Testing
USP <88> In Vivo Biological Reactivity Testing
Solutions
For Consultants Companies
For Start-ups
For Medical Device Manufacturers
For Notified Bodies/FDA
Quality
Resources
MedTech Knowledge Hub
Biocompatibility FAQ
About US
Team
Mission Vision History
Careers at EBI
News
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