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Posted: January 17, 2018

Nelson Labs’ Scientists Awarded Best Published Paper 2017

By: Daniel Olsen, M.S. SM(NRCM) Nelson Laboratories scientists, Michelle Lee, Audrey Turley, and Daniel Olsen, in collaboration with scientists from the Japanese National Institutes of Health, recently published important research for the development of in vitro skin irritation testing for medical devices. Their article, “Proof of concept testing of a positive reference material for in […]

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Posted: December 15, 2017

Martell Winters is Convener for ISO WG16

It was recently announced that Martell Winters, B.S., RM/SM(NRCM) was appointed and approved as convenor for a three-year term of a new ISO working group, WG16, on vaporized hydrogen peroxide sterilization. The new working group is tasked with developing a new standard to provide requirements and guidance for developing sterilization processes for vaporized hydrogen peroxide. […]

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Posted: November 20, 2017

Cytotoxicity Failure Program

Cytotoxicity Failures Cytotoxicity testing is designed to demonstrate if there are cytotoxic leachable substances from medical devices or materials. Cytotoxicity testing is the most sensitive biocompatibility test and is used for safety testing of all medical devices with patient contact.  It is also used frequently as a routine screening test for raw materials. Occasionally, a […]

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Posted: October 31, 2017

Sterigenics International LLC Acquires Toxikon’s European Laboratory Business

Acquisition creates the leading global extractables and leachables lab testing platform to serve the pharmaceutical and medical device industries CLEVELAND, OH. – Oct. 31, 2017—Sterigenics International LLC announced today that it has acquired Toxikon Europe N.V., the European division of Toxikon Corporation, a Bedford, Mass.-based preclinical contract research organization. Terms of the deal were not […]

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Posted: October 25, 2017

AAMI Sterilization Standards Meetings Update

By: Emily Mitzel, MS The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance. One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance (OC), and […]

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