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Understanding the mechanical behaviour of biological tissues and their interactions with medical devices is essential for a better understanding of diseases and injuries, for the development of novel treatment strategies and medical devices and to ensure patient safety.
For example, after implantation, medical products are often subjected to mechanical loading and in mechanical interaction with the surrounding tissues. Good mechanical performance of a medical product is one of the crucial factors to obtain a successful long term clinical outcome.
Mechanical tests provide insight into the mechanical performance and thus into part of the biocompatibility of your product. This insight is necessary in the whole product development cycle as well as at the market entrance stage and afterwards for quality control purposes.
Yes, as stated in the new medical device regulation, biocompatibility is required element for market entrance. Mechanical compatibility is a part of biocompatibility that is often overlooked and that can be an indicator for the long term clinical outcome of a product.
In addition, pre-clinical data, necessary for the application for clinical investigations, have to contain relevant pre-clinical testing and experimental data regarding the mechanical properties of the device.
We can map a broad range of mechanical properties of biological tissues. Usually we start from physiological loading conditions and translate these to relevant in vitro tests. For an accurate characterization of these properties, it is important to mimic the in vivo conditions of the human body as closely as possible, i.e. by creating the right loading conditions and the right testing environment.
Check this video to see how we conduct good mechanical testing of biological tissue. For a detailed overview of our tests, please visit our services page or contact us.
We can map a broad range of mechanical properties of biological tissues. Usually we start from physiological loading conditions and translate these to relevant in vitro tests. For an accurate characterization of these properties, it is important to mimic the in vivo conditions of the human body as closely as possible, i.e. by creating the right loading conditions and the right testing environment.
Check this video to see how we conduct good mechanical testing of biological tissue. For a detailed overview of our tests, please visit our device page.
The lab is located on the KU Leuven Science and Technology campus in Heverlee, Belgium. Visit our contact page to see how you can reach us.
Yes, if you send us a contact request with details about your experiments, you can expect a quote within five working days for standard tests. For custom made tests, our testing engineers will invite you to an (online) meeting to discuss the project. After this meeting, we will provide you with a fully customized quote.
That depends on the nature of the testing services you require: standard tests can usually be performed faster than custom made tests. We aim at testing within three weeks after order. If you have a tight deadline, do let us know so we can discuss the possibilities.
We adapt the report based on your needs. We can provide you with a data report, which includes the necessary values of the testing results. Such a report can be useful if you only need data or if you have done previous tests with us. Otherwise, we always advise a full scientific report, which includes an introduction test, images, and interpretation. Such a high-quality report can be included in the technical file of the medical device for complying with the market entrance process.
Of course. We have an international team with years of experience in mechanical testing for different international collaborations.
Yes, to see examples, please check our testing devices page or browse through the publication page.
Yes, we can. We have access to human and animal tissues and cells through our collaborations within the Leuven University Hospital and KU Leuven.
Biological samples are often shipped to our test facility on ice or on dry ice (following a -80°C freezing). We can recommend the services of specialized carriers for your valuable samples. Do not hesitate to contact us to receive information about our shipping processes.
Yes, this can be a part of our service. We have considerable expertise in developing protocols. When you submit your request, we will discuss the possibilities, depending on the mechanical properties you are interested in.
For custom made tests, we will always start with a pilot test. For standardized tests, we might also begin with a pilot test depending on your product. After this test, you can decide whether and how you want to proceed with the study.
We are working complying with the ISO 17025 quality standard, that guarantees quality management of testing and calibration in laboratories. We have a robust Quality Management System that assures control, validity of test methods and traceability of measurements and samples in every step of the process. You can download our quality policy here.
We work according to internationally accepted standards or guidelines (ISO, ASTM). However, for specific devices or biomaterials (e.g., biological tissues) standards might not be available.
Therefore, we also develop and validate our own standardized testing procedures according to the highest academic standards.
In addition, we are working hard to generate consensus on an international level and develop internationally accepted standards for the testing of biological tissues and biomedical products.
We welcome your questions or comments regarding any service provided. You can find our contact details on the contact page.