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News Articles

ARTICLE

Posted: March 30, 2018

Passing the test: Why patient safety is paramount

By Thor Rollins, Piet Christiaens and Matthew R Jorgensen
Published: Medical Plastics News

Medical plastics permeate the medical device industry with a remarkable diversity of application. They seem to be everywhere in healthcare: from protective barriers and low-risk device components (eg. instrument housings and handles) to devices of the highest potential risk (eg. permanent implants contacting the central nervous system).

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ARTICLE

Posted: March 7, 2018

A Brief Introduction to Medical Device Biocompatibility

By Matthew R. Jorgensen, PhD
Published: MD+DI

Biocompatibility of medical devices is a complex and evolving subject. Here's what you need to know.

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ARTICLE

Posted: January 18, 2018

What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap

By: Trevor Fish and Sarah C. Campbell
Published: MD+DI

Toxicologists offer their perspectives on the future of testing. FDA recently published its Predictive Toxicology Roadmap to enable the adoption of advances in toxicity testing. While this announcement from FDA may not have any immediate effects on the toxicology testing for medical device manufacturers (MDMs), it anticipates the future evolution of toxicology testing. With the unprecedented advancements in technologies, globalization, and ever-changing challenges, FDA and other stakeholders must have a unified, comprehensive strategy. FDA’s Toxicology Working Group recommended a six-part roadmap to achieve the goal of upgrading toxicology tools and their regulatory acceptance for medical devices, pharmaceuticals, and food.

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ARTICLE

Posted: January 4, 2018

ANSI/AAMI PB70: Closing the Gap

By Sarah Smit
Published: MD+DI

Comments from a recent AAMI meeting on revising ANSI/AAMI PB70:2012 “Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities” reveal what changes could be in store for the standard.

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ARTICLE

Posted: December 18, 2017

Regulatory Landscape for EO Residue Levels in Medical Devices

By: Gregory Grams,  Michael Padilla, Peter Strain, Thor Rollins

/asset/s/WhitePaper-EO-Residue-Levels.pdf

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