September 17, 2022
With the rise of orthopedic device evaluation and updating of standards, testing laboratories must be at the forefront of analytical knowledge to partner with orthopedic device makers. In this article, Thor Rollins from Nelson labs and other industry experts share...
See BlogJune 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 BlogJanuary 5, 2021
In October 2020 FDA released a new draft biocompatibility guidance document which focuses on the biological evaluation of devices in contact with intact skin. As a draft document, it is therefore open for comments and possible changes. Release of this...
See BlogSeptember 24, 2020
Irritation testing is identified as one of the most performed biocompatibility tests for medical devices. This is due to the requirement for evaluation which is laid out in ISO 10993-1:2018: Biological evaluation of medical devices –Part 1: Evaluation and testing...
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