June 7, 2022
With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and duration of contact? In this article, Helin Räägel, Matthew R Jorgensen, and Thor Rollins from Nelson Labs share insights on...
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April 7, 2022
This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...
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 BlogJune 3, 2021
Every time there is an update to a standard, especially an overarching one like the ISO 10993-12 standard that covers sample preparation recommendations, it comes with a slight dose of anxiety. This is because it might mean there is now a...
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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