GLP Research Unit – Operating room

At the Silesian Park of Medical Technologies Kardio-Med Silesia, as part of the infrastructure we have, in addition to the Facility for Large Animal and Facility for Small Animal, an operating room, equipped with modern equipment to perform various procedures including surgical, cardiology, urology or ophthalmology. The operating room is a place where many procedures can be performed in vivo, on a model of large animals. Thanks to the GLP quality system, we are able to perform biocompatibility testing for medical devices to the highest standards. Many other procedures can be performed in our facility, thanks to the equipment we have, among other things:

• ablation and cryoablation systems,
• extracorporeal circulation apparatus,
• optical coherence tomography OCT,
• angiograph with 3D angiography capability,
• X-ray machine with mobile C-arm,
• inhalation anesthesia apparatus, ventilators, infusion pumps, defibrillator, ultrasound, ultrasound, treatment tables, surgical instruments,
• apparatuses for biochemical blood determinations.

Thanks to all this modern equipment, we have the ability to conduct a variety of studies not only biological evaluation of medical devices for studies from the PN-EN ISO 10993 group of standards, among others, in vivo on a model of small animals as well as a model of large animals, but also tailored to the needs of a particular experiment, to assess the potential impact of various compounds, medicinal substances on health and life. Trained research staff participating in the treatments as well as in the care of the in vivo model’s welfare ensures the highest standards of the research conducted.

We are certified by Good Laboratory Practice in the biocompatibility tests (scope 9) for biological evaluation of medical devices for tests from the PN-EN ISO 10993 group of standards, including in vivo on a small animal model as well as a large animal model.

Feel free to contact us to match the appropriate test method to your medical device.

Acting in accordance with the requirements specified in Article 32c, point 2 of the Act of November 29, 2000, Atomic Law (consolidated text Journal of Laws 2023, item 1173), we inform you that in the past 12 months, no impact of the conducted activity on human health and the environment has been recorded, and no releases of radioactive substances into the environment have occurred in connection with the conducted activity.