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Author: Audrey P. Turley





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 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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May 7, 2021

In vitro Irritation

Every medical device on the market must be evaluated for its potential to cause irritation, from a knee brace to an artificial cardiac pacemaker, regardless of whether it has a short-term or long-term exposure to the user/patient. This is a...

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February 18, 2021

Requirements and Impact of the New Guideline – ISO 10993-23

The requirements for assessing irritation for medical devices has moved from ISO 10993-10 to ISO 10993-23 and with this new standard comes the inclusion of in vitro irritation testing as a recognized method. This is a critical turning point as...

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