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 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 16, 2016
FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within...
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