Providing biocompatibility testing for various types of medical devices to help manufacturers meet regulatory compliance and achieve global acceptance
In the medical field, practitioners utilise 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 fulfil 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 maximised benefits to patients while minimising 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.
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Ensure the continued recognition of previously approved medical devices that incorporate Tyvek®.