EUROPEAN BIOMEDICAL INSTITUTE

We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices – but not only!

What We Do?

Biocompatibility

Navigate the complexities of biological safety with Europe’s most modern laboratory. We provide end-to-end biocompatibility evaluation to ensure your medical device is safe, compliant, and ready for global markets.

Chemical characterization

Protect patient safety and satisfy regulatory requirements with advanced chemical characterization. We identify and quantify potential chemical risks before they reach the patient.

Microbiology & Sterility

Ensuring the highest standards of microbial safety for medical innovation. EBI provides a full spectrum of microbiological services to validate your sterilization processes and guarantee product safety.

Consulting

Navigate the complexities of MDR and FDA regulations with confidence. We don’t just deliver reports – we ensure your product reaches the market.

European Biomedical Institute

We are specialized in comprehensive biocompatibility testing according to the all series of ISO 10993 biological evaluation of medical devices – but not only! We are constantly developing our labs to offer more services for your medical devices:

Microbiology and sterility testing
Package validation
Reprocessing validation
Consulting services

Why Us?

Tests on time

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Yearly tests

Years of experience

Products registered in FDA and MDR

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European Biomedical Institute profile

We always pay attention to our Customers needs. From the beginning of our history till today, our aim is to offer the highest quality of tests with the shortest possible lead time in a cost effective manner. This is our DNA.

Our certificates

Good Laboratory Practice (GLP). Quality system implemented by European Biomedical Institute. It defines a set of rules and criteria for studies that are planned, performed and monitored, and their results are recorded, reported and archived. It is possible to trace the course of the study or its complete reconstruction. European Biomedical Institute is GLP certified.

ISO 17025 – The quality management standard, implemented to standardize the technical requirements and requirements of management system, intended for research laboratories. Our management system is based on the ISO 17025 standard. European Biomedical Institute is ISO 17025 accredited.

Clients story

"EBI’s professional advice and efficient execution have been instrumental in our device registration. Their laboratory services are truly high-standard."

"Reliable, detail-oriented, and professional. EBI approaches every issue comprehensively, making the complex process of biocompatibility much easier to navigate."

News

ISO 10993-1:2025: Enhanced Characterization, Clearer Risk Logic

The 2025 revision keeps biological evaluation firmly inside ISO 14971 risk management and across the full device life cycle. Your…

ISO 10993-1:2025: Risk Management Integration and Exposure Duration

ISO 10993-1:2025 embeds the biological evaluation within ISO 14971’s risk-management framework. The standard explicitly requires identifying biological hazards, estimating their…

Preparing for Biocompatibility Testing: Strategic Considerations for Medical Device Manufacturers

Biocompatibility testing is essential for every medical device, ensuring safety, regulatory approval, and market success. The process, however, can be…

In Vitro & In Vivo: Strategic Insights for Medical Device Leaders

Biocompatibility testing is not just a regulatory requirement—it is a cornerstone of medical device safety, market approval, and long-term trust….

Biocompatibility Requirements for Wearable Medical Devices: Unique Considerations

Wearable medical devices are transforming healthcare with continuous monitoring, real-time diagnostics, and improved patient engagement. However, their design introduces distinct…

Proactive Planning: Combining Biocompatibility with Other Preclinical Testing Needs

Biocompatibility testing is a vital part of preclinical evaluation, but it’s just one piece of the larger puzzle. Manufacturers often…

ISO 10993-1:2025: Enhanced Characterization, Clearer Risk Logic

ISO 10993-1:2025: Enhanced Characterization, Clearer Risk Logic The 2025 revision keeps biological evaluation firmly inside ISO 14971 risk management and across the full device life cycle. Your plan-and-report pair matters more than ever: the biological evaluation…

ISO 10993-1:2025: Enhanced Characterization, Clearer Risk Logic

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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