Medical Devices
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:
- diagnosis, prevention, monitoring, prediction, prognoses, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information my means of in vitro examination od specimens derived from the human body, including organ, blood and tissue donations,
- control and support of conception and medical devices which does not achieve its principal intended action by pharmacological, immunological or metabolic means in or on the human body, but which may be assisted in its function by such means.
- products specifically intended for the cleaning, disinfection or sterilisation of devices as specifically referred in the Regulation shall also be deemed to be medical devices.
The aim of the biocompatible assessment according to ISO 10993 is that the medical device does not bring about harmful and adverse effects to the patient based on results of series of standardized laboratory tests on the test material or a suitable extract.
The complexity of choosing the right testing of the biocompatibility of medical devices has increased significantly in recent years. The role of InterBioTox is to evaluate the potential toxicological effects of new biomaterials, composite products and the potential exposure to chemical constituents of materials based on the latest parts of ISO 10993 to ensure that humans are protected from the potential biological risks associated with the use of medical devices. The Guideline ISO 10993 demonstrates in very details the different categories in which your medical device can be classified and the corresponding tests for biocompatibility that are necessary for submission.
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...
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...
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...
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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