Contract Manufacturing

Yukon Medical Receives NIH Funding for ClearTip™ Collection Swabs

DURHAM, N.C., January 12, 2021 - Yukon Medical today announced it has been awarded up to $9.4 million by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of the company’s non-absorbent, injection-molded ClearTip™ swabs used for the collection of...

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The Importance of a Manufacturing Quality Plan

What is a Manufacturing Quality Plan? The importance of a manufacturing quality plan can’t be understated in any field, but it’s particularly important in the medical device industry. A quality plan for medical device design and manufacturing is required by the FDA and the ISO 13485 framework....

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SCONE Medical Solutions Inc. Receives EUA for Self-Contained Negative Pressure Environment

MORRISVILLE, N.C., December 21, 2020 - SCONE Medical Solutions Inc. announced today that their product, the Self-Contained Negative Pressure Environment (SCONE™) has been cleared by FDA and is available for sale to hospitals in the United States. The SCONE™ uses negative pressure technology to create "active" barrier...

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Governor of North Carolina Visits Gilero Manufacturing Facility

Yesterday, North Carolina Governor Roy Cooper visited Gilero’s manufacturing facility in Pittsboro, NC. As a medical device company, Gilero felt compelled to find a way to help during the early days of the pandemic.  This past spring, Gilero quickly designed, developed, and began manufacturing a protective face...

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5 Ways to Ensure a Smooth Design Transfer Process

An effective design transfer is critical for medical device manufacturing. When done well, the process is faster, the cost is more economical, and the final product is more likely to meet all design specifications. Done poorly, production is likely to be slowed down, unexpected costs arise, there...

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7 Tips for Successful Medical Device Manufacturing

Transferring a medical device into manufacturing can be challenging. There is a high demand to manufacture devices efficiently, affordably and with a faster time-to-market than ever before. Medical device manufacturers must find innovative solutions to meet these needs while following best practices and regulatory guidelines to ensure...

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What is a Cleanroom & What Happens in One?

What is a Cleanroom? A cleanroom is a controlled environment in which the number of airborne particles is kept to a minimum. These particles could include contaminants such as dust, airborne microbes, aerosol particles and chemical vapors. The contamination level in a cleanroom is specified by the...

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Gilero Scales Up Face Shield Production

Since the World Health Organization characterized COVID-19 as a pandemic in March 2020, Gilero has been working on a number of initiatives to help alleviate shortages of necessary medical equipment. Utilizing our experienced team of design engineers and deep knowledge of the medical device industry, we began...

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North Carolina Working with Local Manufacturers to Make Critical Supplies

RALEIGH, N.C. - North Carolina is working with local manufacturers to shift their production to make critical medical supplies.   In March, Governor Roy Cooper established the state’s Task Force for Emergency Repurposing of Manufacturing (TFERM) to increase the amount of protective gear made here at home....

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Gilero’s Pittsboro, NC Facility Shifts to Face Shield Manufacturing

This article was written by Zachary Horner, Chatham News + Record Staff, and published in Chatham News + Record. The full article can be found here. PITTSBORO — As companies and businesses around the world shift their production focus to making products designed to help fight the...

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