January 28, 2022
According to ISO 10993-1:2018, “the biological evaluation of any material or medical device intended for use in humans shall form part of a structured biological evaluation plan within a risk management process in accordance with ISO 14971.” Based on the...
See BlogOctober 14, 2021
While you may not want to think of the words “worst case” relating to your product, these words are critical in designing a chemical-characterization study and assessing those results in a toxicological-risk assessment. This blog post looks at general concepts...
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 BlogAugust 18, 2015
The landscape of biocompatibility assessment of medical devices is an ever-changing and evolving one. Recently, there has been a lot of effort put into the development of alternatives to in vivo biocompatibility testing. Expanding technological capability and increased scientific understanding...
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