Providing biocompatibility testing for various types of medical devices to help manufacturers meet regulatory compliance and achieve global acceptance
In the medical field, practitioners utilize a range of devices to address patient health, from diagnosis to surgery. When the patient comes into contact with a medical device or material, it should fulfill its intended function without inflicting any harm to the patient. Therefore, all medical devices need to undergo a thorough biological risk assessment to protect the patient from any toxic, physiological, immunogenic or mutagenic effects from the device. This can be achieved with biocompatibility testing.
An integral part of biological risk assessment, biocompatibility testing assesses the compatibility of medical devices with a biological system. It studies the interaction between the device and the various types of living tissues and cells that are exposed to the device when it comes into contact with patients.
The goal for all medical device manufacturers is to provide maximized benefits to patients while minimizing levels of biological risks. This requires them to comply with stringent biocompatibility testing requirements set by international regulatory bodies to ensure that their devices are medically safe to use before being made available in the market.
TÜV SÜD provides a comprehensive range of medical device testing solutions required by relevant regulatory framework worldwide. We offer a complete biocompatibility testing panel for medical devices through our state-of-the-art laboratories, and high standards of data and quality reporting to address the testing needs of small and large-scale manufacturers.
Our team of medical doctors, engineers and toxicologists possess the technical, clinical and regulatory expertise required to thoroughly evaluate biocompatibility test results of medical devices for suitability across global markets. We provide end-to-end assistance with efficient use of resources, while ensuring that project timelines are met with predictability and diligence.
TÜV SÜD is globally recognized for its quality and safety as a third party one-stop testing provider. We offer a suite of testing services required for medical devices and help manufacturers and suppliers independently meet global regulatory standards. Our global network of medical health and services professionals worldwide are recognized as authorities in their fields. Their collective expertise makes TÜV SÜD a trusted partner of choice for manufacturers seeking accreditations in line with medical device regulations.
TÜV SÜD provides the following biological risk assessment tests to help manufacturers meet biocompatibility testing requirements of the International Organization for Standardization (ISO), U.S. Food and Drug Administration (FDA) and American Society for Testing and Materials (ASTM).
Learn about sterilization requirements for reusable medical devices
Discover the specifics of the chemical characterization process, the importance in the overall evaluation of safety.
Comply with MDR Article 117
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