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Posted: November 7, 2017

Sterigenics International LLC Changes Name to Sotera Health LLC

Leverages the strength of Nelson Labs, Nordion and Sterigenics to deliver on its mission of Safeguarding Global Health™

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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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Posted: February 1, 2018

Accelerated Aging Package Testing

By: Pal Khangaldy & Wendy Mach The Packaging Department at Nelson Laboratories is often asked by manufacturers “What do I need to do to validate my packaging?” or “What package testing do I need to have performed in order to comply with regulations?” There is not a one-size-fits-all answer to these questions as unique product, packaging, […]

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Posted: November 8, 2017

Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways

In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.

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