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 and consulting services for medical devices, specializing in ISO 10993 standards. They operate modern laboratory facilities.
**Expertise & scope**
* Expertise in ISO 10993-1:2025, focusing on enhanced characterization and risk logic integration.
* Services include Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER), aligning with ISO 14971 risk management.
* Proficient in chemical characterization (ISO 10993-18) to guide test selection and minimize animal studies.
* Addresses particulate risk assessment, considering manufacturing residuals and wear-generated particles.
* Evaluates foreseeable misuse scenarios and their impact on device categorization and testing.
* Offers a broad spectrum of biocompatibility tests, including Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Toxicity, Implantation, Hemocompatibility, and Genotoxicity.
* Conducts EO & ECH Residual Tests.
* Specializes in biocompatibility requirements for wearable medical devices, considering prolonged skin contact, adhesives, and dynamic environments.
**Reputation / proof points**
* Operates modern laboratory facilities.
* Emphasizes qualified authorship and traceability in biological evaluations, aligning with ISO 14971 requirements.
European Biomedical Institute provides comprehensive biocompatibility testing and consulting services for medical devices, specializing in ISO 10993 standards. They operate modern laboratory facilities.
**Expertise & scope**
* Expertise in ISO 10993-1:2025, focusing on enhanced characterization and risk logic integration.
* Services include Biological Evaluation Plans (BEP) and Biological Evaluation Reports (BER), aligning with ISO 14971 risk management.
* Proficient in chemical characterization (ISO 10993-18) to guide test selection and minimize animal studies.
* Addresses particulate risk assessment, considering manufacturing residuals and wear-generated particles.
* Evaluates foreseeable misuse scenarios and their impact on device categorization and testing.
* Offers a broad spectrum of biocompatibility tests, including Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Toxicity, Implantation, Hemocompatibility, and Genotoxicity.
* Conducts EO & ECH Residual Tests.
* Specializes in biocompatibility requirements for wearable medical devices, considering prolonged skin contact, adhesives, and dynamic environments.
**Reputation / proof points**
* Operates modern laboratory facilities.
* Emphasizes qualified authorship and traceability in biological evaluations, aligning with ISO 14971 requirements.
Additional information
European Biomedical Institute emphasizes the critical role of the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) as integral components of the risk management process, as outlined in ISO 10993-1:2025. They highlight that BEPs are essentially risk plans under ISO 14971, documenting the rationale for all risk decisions. The BER then details how these risks were addressed. Competent personnel are required for planning, conducting, and reporting these evaluations, with an emphasis on qualified authorship and traceability from hazard identification through risk analysis and controls. This structured approach ensures compliance and a thorough understanding of a medical device's biological safety.
Key Highlights
-
Specializes in ISO 10993-1:2025, focusing on enhanced characterization and risk logic.
Source
“The 2025 revision keeps biological evaluation firmly inside ISO 14971 risk management and across the full device life cycle.”
-
Integrates biological evaluations within ISO 14971 risk management framework.
Source
“ISO 10993-1:2025 also formalizes the role of BEPs and BERs (Biological Evaluation Reports) as part of the risk documentation.”
-
Emphasizes chemical characterization (ISO 10993-18) as a central input for evaluation.
Source
“Chemical characterization (ISO 10993-18) is the central input that focus the evaluation and guide test selection”
-
Addresses particulate risk assessment, considering manufacturing residuals and wear-generated particles.
Source
“The standard now calls out physical characteristics as potential risks. Particle generation and material defects (e.g. porosity, sharp edges) can create biological hazards.”
-
Provides comprehensive biocompatibility testing and consulting for medical devices.
Source
“We offer comprehensive pre-clinical testing and consulting services of medical devices.”
Certifications & Trust Signals
-
Operates modern laboratory facilities.
Source
“We have our own laboratories that are among some of the most modern in all of Europe”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliant biocompatibility testing.
- Companies requiring detailed Biological Evaluation Plans (BEP) and Reports (BER).
- Developers of wearable medical devices with unique biocompatibility considerations.
How engagement typically works
- Consultative approach to risk assessment and testing strategy.
- Focus on documented evidence and traceability.
- Collaborative development of BEPs and BERs.
Typical deliverables
- Comprehensive Biological Evaluation Plans (BEP).
- Detailed Biological Evaluation Reports (BER).
- Chemical characterization reports.
- Toxicological risk assessments.
- Results from various ISO 10993 standard tests.
Good to know
- Best when a clear understanding of intended use and potential misuse is available.
- Requires sponsor-provided information on raw materials, packaging, and production conditions for BEP development.
Pricing
Model:
Custom pricing
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>, Other
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
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
No
Nda Support:
Yes
Minimum Project Size:
No minimum
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
< 24 hours
Sample Return Policy:
Dispose
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-18
Test Types Offered
Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Toxicity, Implantation, Hemocompatibility, Genotoxicity, EO & ECH Residual Test, Chemical Characterization
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (>24 h up to 30 days), Long-term (>30 days)
Lead Time Band
Start in 2-4 weeks
Quote SLA
24-48 hours
Sample Return Policy
Dispose
Minimum Project Size
Custom
Pricing Model
Custom
