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biocompatibility

October 10, 2023

FDA Guidance 2023 on ISO 10993-1: What Changed?

This article by biocompatibility experts Helin Räägel, PhD, and Audrey Turley discusses the most recent FDA guidance on biological evaluations of medical devices per ISO 10993-1, highlighting the new guidance on intact skin contact. Read Full Article Learn more about...

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September 13, 2023

Complete Rewrite of ISO 10993-1 Creates Industry Buzz

This article by biocompatibility experts Helin Räägel and Thor Rollins discusses the major upcoming revision of ISO 10993-1. Read Full Article Learn more about the authors below.

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February 1, 2023

Guidance on Combining Biocompatibility and Cleaning Validation Testing

Depending on the type and duration of contact for reusable devices, biocompatibility testing can involve more than ten endpoints that need to be addressed for first-time use and end-of-life use. This can be costly and time consuming. Read this whitepaper...

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December 14, 2021

FDA Reclassifies Surgical Staplers and Staples

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...

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August 29, 2018

LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance

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...

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