Medical Devices

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According to Regulation (EU) 2017/745 of the European parliament and of the Council on Medical Devices , Medical device means any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes::... Read more...

We offer you the necessary tests / studies for a biological evaluation and risk assessment of your medical device according to ISO 10993 in compliance with the principles of Good Laboratory Practice (GLP):

Toxicology Consulting

Our long-standing experts provide a valuable toxicology consultancy for pharmaceutical, medical device and biotechnology products, incl. Toxicological Risk Assessments (TRA), Scientific and medical writing services, Establishing Health-Based Exposure Limits and Extractables and Leachables Studies. Choose the study...

Analytical Chemistry

InterBioTox can assist you in evaluation of the biological safety of a medical device through analytical chemistry for medical devices. This encompasses testing for devices that have direct or indirect body contact in accordance with the relevant standards / ISO 10993 / Part 18: Chemical characterization of materials incl. degradation product identification. We use numerous up-to-date analytical test procedures and equipment under GLP in order to help you fulfil  the analytical requirements. Choose the study...

In vitro Toxicology

There is observed growing efforts to advance the replacement, reduction, and refinement of the use of animals by in vitro alternatives in research, evaluation and testing medical devices. InterBioTox offers you accepted in vitro methods for biocompatibility evaluation of medical devices: cytotoxicity, gene toxicity and test for skin irritation. Choose the study...

In vivo Toxicology

Biocompatibility evaluation of medical device is still done mostly through the testing on animals. InterBioTox offers an array of in vivo testing, working with small animals, and numerous study designs that can be used for biocompatibility evaluations. We offer sensitization, irritation, acute systemic toxicity, subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility studies, all in compliance with GLP. Let our experienced staff help you select or design the right in vivo tests to meet all of your device requirements. Choose the study...


The biocompatibility in vivo testing program includes histopathology and clinical pathology as an integral part of the higher in vivo systemic toxicity studies. All the tests are performed by experienced technical staff, are fitted based on requirements of the ISO guideline, and each represents a number of ways to simulate clinical relevance and to achieve the highest possible quality of data. Choose the study...


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