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 provides comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards. They operate modern laboratory facilities.
**Expertise & scope**
* Comprehensive pre-clinical testing and consulting services for medical devices.
* Expertise in ISO 10993 standards, including biological evaluation plans (BEP).
* Specialized testing includes Chemical Characterization, Toxicological evaluation, and Cytotoxicity.
* Cytotoxicity testing encompasses MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
* Services are designed to assess the interaction between medical devices and biological systems, forming part of the overall device safety assessment.
**Reputation / proof points**
* Operates modern laboratory facilities among some of the most advanced in Europe.
European Biomedical Institute provides comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards. They operate modern laboratory facilities.
**Expertise & scope**
* Comprehensive pre-clinical testing and consulting services for medical devices.
* Expertise in ISO 10993 standards, including biological evaluation plans (BEP).
* Specialized testing includes Chemical Characterization, Toxicological evaluation, and Cytotoxicity.
* Cytotoxicity testing encompasses MEM Elution, Direct Contact, Agar Diffusion, MTT Cytotoxicity, XTT Cytotoxicity, and Neutral Red Uptake.
* Services are designed to assess the interaction between medical devices and biological systems, forming part of the overall device safety assessment.
**Reputation / proof points**
* Operates modern laboratory facilities among some of the most advanced in Europe.
Additional information
European Biomedical Institute emphasizes a risk-based approach to biocompatibility testing, aligning with ISO 10993-1:2018. They assist in developing Biological Evaluation Plans (BEP) to determine potential risks based on device information, raw materials, and packaging. This planning process helps demonstrate compliance with relevant normative requirements and avoid unnecessary testing. Their services are structured to provide good and cost-effective solutions for clients navigating the complexities of medical device safety assessment.
Key Highlights
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Specializes in comprehensive biocompatibility testing for medical devices according to ISO 10993 standards.
Source
“European Biomedical Institute offers comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards.”
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Provides a broad field of biocompatibility tests, including Chemical Characterization, Toxicological evaluation, and various Cytotoxicity assays.
Source
“Below you find a list of biocompatibility tests, that we conduct routinely. Chemical Characterization, Toxicological evaluation, Cytotoxicity”
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Offers consulting services and develops Biological Evaluation Plans (BEP) to support device safety assessment and regulatory compliance.
Source
“Biocompatibility testing data is always required for medical devices with direct and indirect contact. ISO 10993-1:2018 through the Biological Evaluation Plan (BEP) allows to determine the potential risk”
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Operates modern laboratory facilities, described as among the most advanced in Europe.
Source
“We have our own laboratories that are among some of the most modern in all of Europe”
Certifications & Trust Signals
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Adheres to ISO 10993 standards for biological evaluation of medical devices.
Source
“European Biomedical Institute offers comprehensive biocompatibility testing for medical devices, specializing in ISO 10993 standards.”
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Focuses on risk management as a core component of biological evaluation planning.
Source
“Since biological evaluation is a risk management activity, a Biological Evaluation Plan is required”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 compliance testing.
- Companies needing pre-clinical testing and consulting services.
- Organizations seeking to establish device safety through biological evaluation.
How engagement typically works
- Consultative approach to testing strategy.
- Focus on cost-effective solutions.
- Utilizes modern laboratory facilities for testing.
Typical deliverables
- Biocompatibility test reports.
- Biological Evaluation Plans (BEP).
- Chemical Characterization reports.
- Cytotoxicity test results.
Good to know
- Best when specific sample requirements and turnaround times are understood.
Pricing
Model:
Custom pricing
HQ:
PL
Languages:
English
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, Other
Glp Compliant:
No
Has In House Toxicology:
Yes
Toxicology Capabilities:
Extractables and Leachables Testing, Toxicological assessments, Biological reactivity tests
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
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5
Test Types Offered
Chemical Characterization, Toxicological evaluation, Cytotoxicity (MEM Elution, Direct Contact, Agar Diffusion, MTT, XTT, Neutral Red Uptake)
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 4-8 weeks
Quote SLA
4 weeks
Pricing Model
Per project
