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Nelson Laboratories

Your MDR strategy – Start with a gap analysis

November 10, 2020 By Sponsored Content

By Matthew Jorgensen, PhD, DABT- Senior E&L Expert; Audrey Turley- Senior Biocompatibility Expert; Thor Rollins- Director Toxicology and E&L Consulting The 566-page Medical Device Regulation (MDR), which replaces the EU’s Medical Device Directive (93/42/EEC) and the Directive on Active Implantable Medical Devices (90/385/EEC), has caused much discussion, training, debate, and stress in the medical device […]

Filed Under: Sponsored Content Tagged With: Nelson Laboratories

UPDATE: Medtech contract manufacturers make it work during a pandemic

April 29, 2020 By Nancy Crotti

From coping with wild fluctuations in demand to keeping workers safe and customers satisfied, these medical device industry suppliers have managed to adapt amid COVID-19 and an uncharted business environment. Medical device contract manufacturers are finding ways to keep business going during the coronavirus pandemic. Medical Design & Outsourcing recently conducted another round of an informal survey of […]

Filed Under: Business/Financial News, Contract Manufacturing, Distribution, Featured, Outsourcing Tagged With: Biomerics, coronavirus, COVID-19, integer, Medline Industries Inc., microcare, Microspec, Nelson Laboratories, protolabs, qosina, spectrumplastics, Trelleborg, U.S. Centers for Disease Control and Prevention, Web Industries, West Pharmaceutical Services Inc.

Coronavirus & barrier material tests

March 2, 2020 By Sponsored Content

Respirators And Barrier Materials By Sarah Smit, Senior Lab Operations Manager and Janelle Bentz, Study Director III Coronavirus The new strain of coronavirus originating in Wuhan, Hubei Province, China has raised new concerns. This virus is similar to the SARS coronavirus and can cause mild to severe respiratory illness. The virus spreads through droplet transmission. […]

Filed Under: Sponsored Content Tagged With: Nelson Laboratories, nelsonlaboratories

Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives

July 18, 2019 By Nancy Crotti

The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen. Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in […]

Filed Under: Blog, Featured, Food & Drug Administration (FDA), Legal News, News Well, Research & Development, Sterilization / Calibration Tagged With: AdvaMed, FDA, Illinois Environmental Protection Agency, Nelson Laboratories, sterigenics, U.S. Environmental Protection Agency, viant

Sterigenics moves to upgrade shuttered device sterilization plant

June 27, 2019 By Nancy Crotti

Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance, Sterilization / Calibration Tagged With: AdvaMed, American Chemistry Council, arthrex, ArthroCare Corp., becton dickinson, Boston Scientific, Environmental Protection Network, Ethylene Oxide Sterilization Association, FDA, Gamma Processing Industry Alliance, Illinois FDA, Medline Industries Inc., Medtronic, Nelson Laboratories, Smith & Nephew, soterahealth, sterigenics, Stryker, Teleflex

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