Contract Manufacturing

An Interview with Gilero’s Vice President of Manufacturing 

Wade Stauffer is the Vice President of Manufacturing at Gilero. Working out of our contract manufacturing facility in Pittsboro, North Carolina, Wade makes sure that all areas of the plant run smoothly while overseeing the manufacturing growth operations across the entire company. What does a typical day...

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An Interview with Gilero’s Vice President of Technical Operations

Eli Nichols is the VP of Technical Operations at Gilero, where he uses his extensive engineering background and breadth of medical device knowledge to oversee Gilero’s design transfer team. Learn more about why Gilero has a dedicated team for transferring designs into manufacturing, and Eli’s role in...

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Understanding 21 CFR Part 211

What is 21 CFR Part 211? The Code of Federal Regulations Title 21 Part 211 refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. These requirements are meant to ensure that finished drug product is handled in a way that does...

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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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