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 […]
Nelson Laboratories
UPDATE: Medtech contract manufacturers make it work during a pandemic
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 […]
Coronavirus & barrier material tests
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. […]
Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives
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 […]
Sterigenics moves to upgrade shuttered device sterilization plant
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 […]
