March 21, 2022
Six steps to assess the situation and determine how to move forward… Each medical device present or coming on the market needs to have a demonstrated biocompatibility to protect users from potential biological risks arising from its intended clinical use....
See BlogFebruary 14, 2022
Cytotoxicity endpoint is marked for all medical devices that contact the patient/user, regardless of type or duration of contact. A cytotoxicity test is an in vitro cell culture assay where the medical-device extract is placed in contact with mammalian fibroblast...
See BlogMay 26, 2021
To ensure patient safety, medical device manufacturers are required by the Food and Drug Administration and other regulatory bodies to perform biocompatibility evaluations on their devices per standards, such as the AAMI-approved ISO 10993-1:2018 (ANSI/AAMI/ISO 10993-1:2018). However, some of these...
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