European Biomedical Institute
European Biomedical Institute offers comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards. They provide pre-clinical testing and consulting with modern laboratory facilities.
The European Biomedical Institute (EBI) is a leading provider of comprehensive biocompatibility testing and pre-clinical services for medical devices. Specializing in the ISO 10993 series, EBI offers a broad spectrum of tests, including Biological Evaluation Plans (BEP) and Reports (BER), Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Toxicity, Implantation, Hemocompatibility, Genotoxicity, and EO & ECH Residual Testing. EBI's state-of-the-art laboratories are among the most modern in Europe, enabling them to conduct a wide range of tests with a focus on risk management integration as per the latest ISO 10993-1:2025 revisions. They emphasize a risk-based approach, leveraging chemical characterization and minimizing animal studies where possible. Their services support the full device lifecycle, from initial planning to post-market surveillance, ensuring compliance with regulatory requirements. With a commitment to providing cost-effective solutions and expert consulting, EBI assists clients in navigating the complexities of medical device safety assessment. Their team of qualified and experienced professionals ensures that all evaluations are conducted with rigorous scientific integrity and documented traceability, aligning with ISO 14971 principles.
About
**Who they are**
European Biomedical Institute (EBI) is a provider specializing in comprehensive biocompatibility testing for medical devices, with a particular focus on ISO 10993 standards.
**Expertise & scope**
* Offers pre-clinical testing and consulting services for medical devices.
* Specializes in ISO 10993 standards, including Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER).
* Expertise covers chemical characterization, cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, toxicity, implantation, hemocompatibility, genotoxicity, and EO & ECH Residual Tests.
* Addresses the 2025 revision of ISO 10993-1, emphasizing risk management, chemical characterization, and physical characteristics as potential risks.
* Provides guidance on foreseeable misuse scenarios and their impact on risk assessment and testing strategy.
**Reputation / proof points**
* Operates modern laboratory facilities.
* Has offices in Poland, Germany, and the USA.
European Biomedical Institute (EBI) is a provider specializing in comprehensive biocompatibility testing for medical devices, with a particular focus on ISO 10993 standards.
**Expertise & scope**
* Offers pre-clinical testing and consulting services for medical devices.
* Specializes in ISO 10993 standards, including Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER).
* Expertise covers chemical characterization, cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, toxicity, implantation, hemocompatibility, genotoxicity, and EO & ECH Residual Tests.
* Addresses the 2025 revision of ISO 10993-1, emphasizing risk management, chemical characterization, and physical characteristics as potential risks.
* Provides guidance on foreseeable misuse scenarios and their impact on risk assessment and testing strategy.
**Reputation / proof points**
* Operates modern laboratory facilities.
* Has offices in Poland, Germany, and the USA.
Additional information
European Biomedical Institute emphasizes a risk-based approach to biocompatibility testing, aligning with ISO 14971. They highlight the importance of detailed Biological Evaluation Plans (BEP) that outline intended use, hazards, gap analysis, and testing strategies. The Biological Evaluation Report (BER) demonstrates conformance to the plan and justifies test selection or waivers. EBI also addresses physical characteristics like particle generation and material defects as potential biological hazards, integrating these into the risk assessment. Their services are designed to help clients navigate complex regulatory requirements and ensure the safety of medical devices.
Key Highlights
-
Specializes in comprehensive biocompatibility testing for medical devices, focusing on ISO 10993 standards.
Source
“European Biomedical Institute offers comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards.”
-
Provides detailed Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER) as part of the risk management process.
Source
“Your plan-and-report pair matters more than ever: the biological evaluation plan (BEP) must spell out intended use... the biological evaluation report (BER) must show conformance to the plan...”
-
Offers a broad range of biocompatibility tests including Cytotoxicity, Sensitization, Irritation, Implantation, and Hemocompatibility.
Source
“Below you find a list of biocompatibility tests, that we conduct routinely. Chemical CharacterizationToxicological evaluation”
-
Addresses the latest ISO 10993-1:2025 revisions, emphasizing chemical characterization and physical risks.
Source
“The 2025 revision keeps biological evaluation firmly inside ISO 14971 risk management... The standard now leans first on information. Chemical characterization (ISO 10993-18) is the central input...”
Certifications & Trust Signals
-
Operates modern laboratory facilities for pre-clinical testing.
Source
“We have our own laboratories that are among some of the most modern in all of Europe...”
-
Provides consulting services alongside testing to guide clients through regulatory requirements.
Source
“European Biomedical Institute offers comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards. They provide pre-clinical testing and consulting...”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance.
- Companies requiring detailed biocompatibility testing and risk assessment.
How engagement typically works
- Consultative approach to planning and testing.
- Collaborative development of BEPs and BERs.
Typical deliverables
- Biological Evaluation Plans (BEP)
- Biological Evaluation Reports (BER)
- Chemical Characterization reports
- Cytotoxicity testing
- Sensitization testing
- Irritation testing
Good to know
- Best when a comprehensive understanding of ISO 10993 and risk management is required.
- Ideal for devices requiring pre-clinical testing and regulatory documentation.
HQ:
Józefów k/Otwocka, PL
Languages:
English
Timezones:
UTC+1
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-18, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Pharmacokinetics, Other
Glp Compliant:
No
Has In House Toxicology:
Yes
Toxicology Capabilities:
Pre-clinical testing and consulting services of medical devices.
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
No
Nda Support:
No
Minimum Project Size:
No minimum
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
< 24 hours
Sample Return Policy:
Dispose
Sample Requirements:
The BEP should assess if particles could dislodge and where they might accumulate. For each, the BEP should assess if particles could dislodge and where they might accumulate. Notably, particles that bioaccumulate in tissue effectively lengthen exposure – ISO 10993-1 now requires treating those cases as long-term exposure.
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Biological Evaluation Plan (BEP), Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Toxicity, Implantation, Hemocompatibility, Genotoxicity, Biological Evaluation Report, EO & ECH Residual Test
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 2-4 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Per project
