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Biocompatibility

The concept of biocompatibility refers to the interaction between the tissues and the physiological systems of a patient treated with a medical device. The biocompatibility assessment is part of the overall device safety assessment.

Extractables & Leachables

Extractables and Leachables Testing is an analysis of potentially harmful materials that could be administered to a patient with a drug or device. Toxicological assessments may then be made, to quantify a patient’s exposure to each chemical and gauge the level of risk posed by these materials.

Biological reactivity USP

Biological reactivity tests of elastomerics, plastics and other polymeric materials that have direct or indirect contact with the patient were designed to determine the biological in vitro , in vivo response. Based on different plastics class various tests need to be conducted according to Table 1: Classification of Plastics of USP <88> , USP <87>.

Other Services

We offer pre-clinical testing and consulting services of medical devices. We have our own laboratories that are among some of the most modern in all of Europe and we are proud to say we have a very broad field of tests we are able to conduct.

ABOUT US

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

LATEST

NEWS

Młodszy specjalista ds. jakości

Młodszy specjalista ds. jakości Stanowisko: Młodszy specjalista ds. jakości Miejsce pracy: Józefów k/Otwocka.   W Europejskim Instytucie Biomedycznym wykonujemy badania przedkliniczne, a także wymyślamy innowacyjne biowyroby dla chirurgii. Posiadamy jedne z...

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EO & ECH Residual Test

Ethylene oxide gas (EO) is a flammable and colorless gas commonly used in medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization...

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Osoba techniczna

Osoba techniczna Stanowisko: Osoba techniczna Miejsce pracy: Józefów k/Otwocka.   W Europejskim Instytucie Biomedycznym wykonujemy badania przedkliniczne, a także wymyślamy innowacyjne biowyroby dla chirurgii. Posiadamy jedne z najnowocześniejszych laboratoriów w...

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Asystent opiekuna zwierząt/ technik weterynarii

Asystent opiekuna zwierząt/ technik weterynarii Stanowisko: Asystent opiekuna zwierząt/ technik weterynarii Miejsce pracy: Józefów k/Otwocka.   W Europejskim Instytucie Biomedycznym wykonujemy badania przedkliniczne, a także wymyślamy innowacyjne biowyroby dla...

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Młodszy specjalista ds. badań in vitro

Młodszy specjalista ds. badań in vitro Stanowisko: Młodszy specjalista ds. badań in vitro Miejsce pracy: Józefów k/Otwocka.   Europejski Instytut Biomedyczny Sp. z o.o. jest liderem w Polsce w dziedzinie badań biokompatybilności wyrobów medycznych. Naszą misją...

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Młodszy Specjalista ds. Analiz Chemicznych

Młodszy Specjalista ds. Analiz Chemicznych Stanowisko: Młodszy Specjalista ds. Analiz Chemicznych Miejsce pracy: Józefów k/Otwocka.   Europejski Instytut Biomedyczny Sp. z o.o. jest liderem w Polsce w dziedzinie badań biokompatybilności wyrobów medycznych. Naszą...

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The Importance of BEP and BER

The Importance of BEP and BER The Importance of Biological Evaluation Plan and Report in Medical Devices Authors: Bartosz Gromadka1, Łukasz Szymański1, Damian Matak1 1 European Biomedical Institute, Józefów, Poland * info@ebi.bio; https://ebi.bio/ Keywords:...

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Biocompatibility Testing in Medical Devices Conference

Biocompatibility Testing in Medical Devices Conference We are pleased to announce that the European Biomedical Institute will be a sponsor of Biocompatibility Testing in Medical Devices Hybrid Conference.  The event will take place on April 20, 2023 – April 21,...

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Młodszy specjalista ds. badań in vitro

Młodszy specjalista ds. badań in vitro Miejsce pracy: Józefów k/Otwocka. Aktualnie poszukujemy osoby na stanowisko Technik weterynarii i/lub Zootechnik, która będzie sprawować opiekę nad zwierzętami (myszy, szczury, kawie domowe, króliki) oraz dbać o porządek po...

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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.

 

CERTIFICATES

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.