Contract Manufacturing

How Prototype Tooling Can Be a Smarter Alternative to Production Tooling

Tool selection is important to the medical device design and development and manufacturing processes, one that can make or break a project, and it’s not a cut-and-dry decision. There are actually three different types of tooling: prototype tooling, bridge tooling, and production tooling. Each type has its...

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623 Medical Announces the Launch of Nüm, a Novel Sterile Topical Anesthetic Spray

MORRISVILLE, N.C., June 1, 2021 - 623 Medical has announced that their first commercial product, nüm, has been cleared by the FDA and is now available for sale in the US market. Nüm is a sterile topical anesthetic spray used to numb the skin prior to needle...

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Yukon Medical Granted Formal Approval to Sell ClearTip™ Swabs in the European Union

DURHAM, N.C., May 18, 2021 - Durham-based medical device company Yukon Medical announced today that it has been granted formal approval to sell ClearTip™ swabs (specimen collection devices) in the European Union. The announcement comes four months after the domestic listing of ClearTip swabs with the US...

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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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