May 25, 2023
“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A critical change with MDR is the clinical evidence necessary to demonstrate the safety and efficacy of the device… Manufacturers must...
See BlogSeptember 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...
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Join us for a free one-day pharma seminar and open house at our Nelson Labs Itasca, IL Facility on June 22, 2023. |
