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Introducing RapidCert™ Biological Indicator (BI) Sterility Testing — Nelson Labs’ patent-pending solution for quicker sterility confirmation. Learn More
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Author: Audrey P. Turley





September 23, 2025

ISO 10993-1 FDIS Updates: What the Risk-Based Approach, Particulates, and Contact Time Changes Mean for Medical Device Teams

The Final Draft International Standard (FDIS) of ISO 10993-1 introduces the most significant updates in decades to the biological evaluation of medical devices. Among other things, these revisions reinforce a risk-based framework aligned with ISO 14971, expand expectations for particulate...

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August 19, 2025

Impact of Device Changes on Biocompatibility

Even small modifications to a medical device, whether materials, processes, or sterilization methods can significantly affect its biological safety. This whitepaper provides a risk-based framework, grounded in ISO 10993-1 and ISO 14971, for evaluating when and how to reassess biocompatibility...

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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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April 13, 2023

Nelson Labs is an ASCA Accredited Testing Laboratory!

Nelson Labs has recently received ASCA accreditation for Biocompatibility, specifically cytotoxicity and sample preparation (ID TL-65). The Accreditation Scheme for Conformity Assessment (ASCA) is offered through the FDA CDRH Standards and Conformity Assessment Program (S-CAP). The goals of the ASCA...

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April 11, 2023

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

This article discusses the most recent FDA pilot program which supports streamlined regulatory submission processes for medical device manufacturers enhancing efficiency for FDA reviews. Read Full Article Learn more about the authors below.

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