December 14, 2021
The FDA has reclassified surgical staplers and staples from Class I to Class II devices, requiring them to undergo premarket review. Since they have been reclassified, these devices will now be subject to more stringent regulatory requirements, such as premarket...
See BlogAugust 29, 2018
Register HERE for the three-day live webinar series “How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance” presented by Nelson Laboratories’ experts: Thor Rollins, Sarah Campbell, and Audrey Turley. This three-day webinar will incorporate the new US FDA...
See BlogJune 20, 2018
Incorporating Biocompatibility, Chemistry, and Toxicology into your Biological Risk Evaluation In the past, biocompatibility consisted of determining the contact of your medical device, looking at the Table A.1 in ISO 10993-1 and running the test prescribed. This approach put too...
See BlogSeptember 15, 2017
For over a decade, Nelson Laboratories has been hosting educational seminars called The Science of Sterilization Validation. The aim of these three-day seminars has been to provide MedTech professionals the opportunity to establish or refresh their fundamental testing knowledge and,...
See BlogSeptember 13, 2016
Martell Winters, consultant and senior scientist at Nelson Laboratories, is now instructing a course at Brigham Young University (BYU) entitled “Industrial Microbiology and Sterilization.” The course is limited to juniors, seniors, and graduate students and is focused on providing a...
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