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Author: Audrey P. Turley





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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April 7, 2022

Biocompatibility Fundamentals for Medical Devices eBook

This eBook contains guidelines for planning, risk mitigation, testing, and compliance for the design and manufacture of medical devices. It provides a digest of pressing challenges and solutions for medical-device design, development, and testing with regard to biocompatibility and toxicology...

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May 26, 2021

26th of May 2021, A Day Many Medical Device Manufacturers Will Never Forget…

It is D-day, or the Day of Application (DoA) for the Medical Device Regulation (MDR) EU 2017/745. Years of hard work have preceded this date to prepare for this new regulation. The key message of the MDR is to minimize...

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