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Fast-Track Your Medical Device Approval with Comprehensive Biocompatibility Testing

ISO 17025 Accredited & GLP Certified Labs. We handle the entire testing process for MDR and FDA compliance – delivering results on time, with zero hidden costs.

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From A to Z Chemical Characterization
& Biocompatibility

From BEP (Biological Evaluation Plan) to final BER (Biological Evaluation Report), we manage the whole testing process under ISO 10993 standards.

Comprehensive Testing Scope (All-inclusive ISO 10993 testing services)

Chemical Characterization

Toxicological Risk Assessment

Consulting & Strategy (Avoid unnecessary tests)

Global Reach, Local Touch: Operating as EBI in Europe and NABI in the USA, we combine 20+ years of expertise with a state-of-the-art laboratory to reduce your costs and delivery times.

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Tired of Waiting for Results?

  • Speed Matters - Over 99% of our reports are delivered before the deadline. No massive backlogs. We start your tests immediately after sample reception.
  • Global Acceptance - Our reports are recognized by Competent Authorities and Notified Bodies worldwide. Whether you target CE marking or FDA approval, we’ve got you covered.
  • Free Regulatory Support - We don't just hand you a report and leave. We support you with Notified Body queries on testing free of charge until your registration is complete.

We know that in the medical device industry, time is money! While other labs struggle with backlogs and slow communication, EBI & NABI deliver certainty.

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Your Path to Compliance in 4 Simple Phases

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?

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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.

Clients story

Our company entrusted EBI with the preparation of the Biological Evaluation Plan (BEP) for two Drug–Device Combination Products (pen and cream pump).The biocompatibility testing strategy, the supporting documentation, and the test reports developed by EBI were positively assessed by the Notified Body during the Notified Body Opinion (NBO) procedure. Based on the quality of the deliverables, regulatory compliance, and positive NB evaluation, EBI has demonstrated strong technical and scientific competence in the area of biological safety evaluation for combination products. Therefore, collaboration with EBI is highly recommended for future projects of similar scope and regulatory complexity.
Kamil KononSenior Quality Manager, Theramex
We have been cooperating with EBI for several years. We are satisfied with the services that it offers and performs in the field of biocompatibility tests of medical devices. EBI employees have a lot of knowledge in this aspect and professionally fulfill their tasks, they also help in the selection of research. The prices of services offered by the company are also attractive.
MiłoszPoland
Cooperation with EBI was quick and successful in every case. The company provides services reliably, taking care of every detail, and thus the whole topic. The attitude of employees to clients is professional, they approach each issue comprehensively, offering a wide range of services.
AdamPoland

Contact with us

We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.

Direct contact:

Mail:
contact@ebi.bio

Phone:
+48 22 780 06 32

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