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medical device Industry

September 13, 2016

Martell Winters Shares Expertise with University Students

Martell Winters, consultant and senior scientist at Nelson Laboratories, is now instructing a course at Brigham Young University (BYU) entitled “Industrial Microbiology and Sterilization.” The course is limited to juniors, seniors, and graduate students and is focused on providing a...

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April 12, 2016

3D Printed Devices and Biocompatibility

The use of three-dimensional (3D) printing techniques to address challenging fabrication problems has become mainstream over the past decade. While this rich resource has extended fabrication of personalized medical devices to the limit of our imagination, the myriad materials and...

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March 25, 2016

FDA Proposes Ban on Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Gloves

FDA is proposing to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s gloves. The Agency determined that an unreasonable and substantial risk of illness or injury may occur from using these medical products and...

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March 8, 2016

Estimated Economic Impacts of the Two Year Moratorium on the Medical Device Excise Tax

We may be seeing an increase in activity from medical device manufacturers as a result of the Consolidated Appropriations Act, 2016 (Pub. L. 114-113) which lifted the Medical Device Excise Tax for two years beginning January 1, 2016. Since January...

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September 9, 2015

Improving Medical Device Approval Timelines

The business of getting medical devices to market is a complex web of variables including the laboratory testing we do at Nelson Labs. We know that an intimate knowledge of regulatory behavior, draft guidance and guidance documents can significantly improve...

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