Tag: Repair
FDA releases guidance on ‘remanufacturing’ of devices
May 13, 2024HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s extensive review of post-market information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing”...
Compass Health adds Quality Biomedical to network
December 26, 2023HME News Staff
MIDDLEBURG HEIGHTS, Ohio – Compass Health Brands has expanded its authorized service center network with the addition of Quality Biomedical. Through this new agreement, the Boulder, Colo.-based Quality Biomedical will support Compass Health customers with in-warranty and out-of-warranty repairs for stationary and portable oxygen concentrators, CPAP and BiPAP devices, ventilators and other equipment. “Partnering with Quality Biomedical dovetails perfectly with Compass Health’s focus...
CAIRE opens new service HQ
October 25, 2023HME News Staff
BALL GROUND, Ga. — CAIRE Inc. has opened a new global service headquarters in Canton, Ga., near its primary manufacturing hub north of Atlanta. The 29,500-square-foot Canton facility will provide rapid servicing of equipment, as well as fulfillment of specialty service parts and accessories for CAIRE respiratory and specific AirSep brand commercial products. “As we navigated the challenges of the pandemic, we discovered there was an opportunity to improve the efficiency of our service...
Quality Biomedical launches new technology
November 29, 2022HME News Staff
BOULDER, Colo. – Quality Biomedical has launched QTags, a QR code label that’s integrated with the company’s management platform QConnect, to help its provider customers better track equipment. “Customers often commented about the time required to generate RMAs, and their ability to accurately track the equipment they sent for service and received back after service” said Jim Worrell, chief commercial officer of Quality Biomedical. “We listened to those concerns...
Philips recall: Senator pushes for answers
August 30, 2021HME News Staff
WASHINGTON – Sen. Richard Blumenthal, D-Conn., sent a three-page letter to Vitor Rocha, the CEO of Philips North America, on Aug. 24, asking him to answer seven questions, including, when does Philips expect to have repaired or replaced all impacted devices?
Blumenthal writes that he has heard from constituents with concerns about the lack of information surrounding a recall of certain Philips CPAP devices and ventilators announced in June.
“The current situation is...
Stakeholders: Recall alert is misleading
August 26, 2021HME News Staff
WASHINGTON – Industry stakeholders are pushing back on a CMS alert that, they say, makes it seem like patients can get CPAP devices and ventilators affected by a recent Philips recall replaced or repaired right away.
The alert states: “If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than five years old. If the equipment is more...
Quality Medical Group, at your service
October 7, 2019Liz Beaulieu, Editor
SOMERSET, N.J. - Quality Medical Group, in its 20th year of business, wants to expand its business nationally with support from a new 25,000-square-foot home base here.The company, which services complex respiratory equipment like ventilators for a range of providers, including HME providers, also has support offices in Pennsylvania, Maryland and Delaware, and employs about 60 people.“We'd like to reach our depot business—when equipment comes in to our shop to be repaired/troubleshot—across...
Quality Biomedical takes on investor to build nationwide presence and expand beyond HME
September 10, 2019HME News Staff
BOULDER, Colo. - Quality Biomedical has completed an outside investment by Aeonic Partners, a New York-based private equity firm. It's the first institutional investor for Quality Biomedical, which provides integrated logistics, warehousing, service/repair, documentation management and other related services, all underpinned by its Q-Connect technology platform. Quality Biomedical will use the investment for “Phase 2 of its growth strategy,” which includes opening new service centers...
Quality Biomedical tapped by GCE for service
August 20, 2019HME News Staff
BOULDER, Colo. - Quality Biomedical has been appointed a national service provider by GCE Group. Quality Biomedical will provide both warranty and out-of-warranty service and repair for GCE's Zen-O and Zen-O Lite range of portable oxygen concentrators starting Aug. 23. Jim Clement, GCE's general manager of operations in the U.S., said a big factor in the company's decision was Quality Biomedical's national presence in five major markets, with plans to expand to 12 over the next 18...
Quality Biomedical does brisk business in Boulder
July 9, 2019HME News Staff
BOULDER, Colo. - Quality Biomedical has doubled the size of its service center here. The center, which specializes in repairing respiratory equipment, including vents, POCs and apnea monitors, has received business orders from Colorado, Wyoming, Nebraska, Nevada and California. “We knew this was an underserved area of the country when we opened our service center in Boulder last year,” said Jim Worrell, chief commercial officer, “but we did not expect to grow this fast.” In...