About Us
European Biomedical Institute (EBI) is an independent Contract Research Organization (CRO) dedicated to bridging the gap between innovative medical device design and global regulatory compliance.
Our Mission & Heritage
For over 20 years, EBI has been at the forefront of preclinical medical device testing. What started as a vision to provide high-quality laboratory services has evolved into one of the most modern, independent testing facilities in Europe.
Our DNA is simple: Quality, Speed, and Transparency. We don’t just provide data; we provide the certainty that your medical device is safe for patients and ready for the global market.
Why EBI Stands Out
- In-House Control: We perform biocompatibility and chemistry testing 100% in-house. This means no subcontracting delays and full control over your samples.
- Modern Infrastructure: Our laboratories are equipped with the latest technology for analytical chemistry and biological evaluation.
- Regulatory Recognition: Our reports are trusted by Notified Bodies and Competent Authorities (FDA, MHLW, MFDS, ANVISA) worldwide.
- Expert Guidance: We leverage two decades of experience to advise you on cost-effective approaches, often eliminating unnecessary tests and saving your budget.
Comprehensive Scope of Expertise
We specialize in a full spectrum of preclinical services, including:
- Complete ISO 10993 Biocompatibility (In vitro, in vivo, and in silico)
- Chemical Characterization (E&L, FT-IR, UV-VIS, TOC, ICP-MS)
- Toxicological Assessments (BER, BRA, and BEP development)
- Microbiology & Sterility (Validations for cleaning, disinfection, and sterilization)
- Packaging Validation (Ensuring integrity and shelf-life)
- Specialized Testing (USP 87 & 88 for polymeric materials)
Global Standards & Quality Systems
Quality is not an option; it is our foundation. EBI operates under the most rigorous international standards:
- GLP (Good Laboratory Practice): Our GLP certification ensures that every study is planned, performed, and reported with absolute traceability and integrity.
- ISO 17025 Accreditation: This standard confirms our technical competence and the reliability of our laboratory results.
- FDA 21 CFR Part 58 Compliance: Essential for manufacturers targeting the U.S. market.
What Our Partners Say
Section 6: EBI by the Numbers
- 20+ Years of experience in MedTech.
- >96.6% of reports delivered before the deadline.
- 4.6/5 Customer Satisfaction Rating.
- 0 Reports rejected by FDA/Notified Bodies due to lab errors.
Why Choose EBI Laboratories?
Modern Infrastructure:
Our labs are among the most technologically advanced in Europe, ensuring high precision and reproducible results.
Cost-Effective Solutions:
We advise on the most efficient testing routes, often using chemical characterization and rationales to avoid unnecessary biological tests.
Regulatory Authority:
Our reports are designed for seamless acceptance by Notified Bodies (CE Mark), the FDA, and other global regulators.
ISO 17025 Accredited:
Highest quality standards for testing and calibration.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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