News

Medical Device Quality Control vs Quality Assurance

The last thing a medical device manufacturer wants is for a piece of equipment to malfunction once it gets into the hands of a clinician, patient or caregiver. With such high stakes, the emphasis on quality when it comes to this form of design and manufacturing is...

20 Jan, 2021

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...

17 Jan, 2021

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....

03 Jan, 2021

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...

21 Dec, 2020

An End-of-Year Interview with Gilero’s CEO

It’s safe to say that 2020 did not go the way any of us planned.  I sat down (virtually, of course) with Ted Mosler, Founder and Chief Executive Officer of Gilero, to discuss the state of the company and plans for the future as this year finally...

17 Dec, 2020

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...

04 Dec, 2020

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...

30 Nov, 2020

Could Grant Money Help Pay for Your Medical Device Project?

The design and development process for a new medical device can be costly. For companies and projects that meet certain criteria, applying for a grant may be a viable option to secure the funding needed for these medical device projects. In its most basic sense, a grant...

09 Nov, 2020