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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
CONTACT
Kategoria: Uncategorized
Our Customer successfully registered his product in CFDA!
We are proud to inform, that our Customer successfully registered his product in CFDA (Chinese Food and Drug Administration) based…
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Irritation or Intracutaneous
Irritation or Intracutaneous reactivity Did you know that Irritation or Intracutaneous reactivity is one of two in vivo biological endpoints…
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The sensitization test
The sensitization test The sensitization test is the second, except for the irritation test, in vivo biological endpoint to be…
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PYROGENICITY in EBI
PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response. Pyrogenic responses may be…
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Medical devices, that come to contact with blood
An important part of the products we handle are medical devices, that come to contact with blood (blood paths, circulating…
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Genotoxicity studies, carried out according to ISO 10993-3 and 10993-33
One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3…
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EBI is ISO 17025 accredited!
By the decision of the Polish Accreditation Center (PCA), we obtained ISO 17025 accreditation! From this moment, European Biomedical Institute…
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ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation.
ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation. The long-awaited ISO 10993-23 Biological evaluation of…
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New Walletmor payment implant certified by ISO tests in Konmex BioLabs!
We are heappy to annouce that the Walletmor payment implant has successfully passed cytotoxic testing. Check more!…
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