Biocompatibility is one of the key requirements for demonstrating medical device safety, and iuvo brings decades of experience in testing to support your product launch.
iuvo performs the full gamut of ISO 10993 biocompatibility tests. Combining our testing experience with our toxicology advisory services, our experts can guide you from strategy development, through all of the testing required for submission of new devices, as well as for evaluation of materials or manufacturing changes.
The ISO 10993-1:2018 matrix (provided below) is a guide to which endpoints need to be considered for different types of devices based upon the nature of body contact and the contact duration, but this is really the starting point in assessment. We can work with you on a risk-based approach to biocompatibility testing, to help you identify the most appropriate and cost effective strategy for your device.
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