Meet EBI at MEDICA 2024!
YOUR TRUSTED TESTING PARTNER
Schedule an appointment with us for MEDICA 2024 in Düsseldorf!
Register now!
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Meet us at MEDICA
Visit our stand at the agreed time. We look forward to meet you!
MEET US AT MEDICA IN DÜSSELDORF IN THE POP UP CONFERENCE ROOM, IN HALL 13
ATTEND OUR SEMINAR AND SCHEDULE YOUR B2B MEETING WITH US ON 12TH AND 13TH NOVEMBER!
EBI Seminar: 13:30 to 14:00 on Tuesday, 15:30 to 16:00 on Wednesday
ABOUT US
As European Biomedical Institute we are independent Contract Research Organization (CRO) mainly focused on providing comprehensive biocompatibility and chemistry testing for medical devices according to the ISO 10993, in-house. European Biomedical Institute is ISO 17025 accredited, Good Laboratory Practice (GLP) certified, and US FDA 21CFR58 compliant, which allows us to meet the most restricted requirements of Competent Authorities (e.g. FDA, MHLW, MFDS, ANVISA) and Notified Bodies.
Introduction of ebi
We are specialized in comprehensive in vitro, in vivo and in silico preclinical medical device testing institute. Furthermore, we constantly develop our laboratories, therefore at European Biomedical Institute our services also include, but are not limited to:
- Complete ISO 10993 biocompatibility
- Biological Evaluation Plan (BEP), Biological Evaluation Report (BER), Biological Risk
- Physical and chemical characterization, extractable and leachable (E&L) – ISO 10993-18
- Microbiology and sterility – ISO 11737
- Cleaning, disinfection and sterilization validations
- Package validation – ISO 11607
- Toxicology – ISO 10993-17
- Biological reactivity of elastomerics, plastics and other polymeric materials USP 87, USP 88
Advantages of testing with ebi
- ISO 17025 & GLP Certified and partner with Notified Bodies: EBI adheres to top international standards for testing accuracy and regulatory compliance, and serves as a partner lab for notified bodies, ensuring your products meet the highest regulatory expectations.
- Comprehensive Biocompatibility Testing: EBI specializes in biocompatibility testing according to ISO 10993, offering a wide range of services such as cytotoxicity, genotoxicity, hemocompatibility, and irritation testing.
- Time performance: With over 96.1% of tests completed well ahead of schedule in 2022, EBI prides itself on delivering results before deadlines.
- Expert Regulatory Compliance Support: EBI provides extensive regulatory guidance for medical device testing, helping clients navigate the complexities of global regulations, including those from the FDA, EU, and other authorities
- Cutting-Edge Facilities and Techniques: Equipped with modern technology like Individual Ventilated Cages (IVC) for animal care and advanced testing equipment, EBI maintains rigorous environmental controls to ensure optimal test conditions
- Global presence: EBI’s global reach includes laboratories in the UK, Poland, and other locations worldwide.
