Circadiance Receives Expanded ISO 13485 Certificate and CE Marking Ahead of Schedule

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These new approvals allow Circadiance to complete the rebranding of the SmartMonitor and NeoPAP product lines to fully capitalize on the interest that several international distributors have expressed in Circadiance’s pediatric solutions.

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This is a significant milestone for our organization, one which reinforces the high standards that Circadiance consistently achieves relative to its product quality and business processes. - David Groll, CEO of Circadiance

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Circadiance’s recent acquisition of two new product lines put the company in both an enviable and challenging position. Enviable in that it had two popular pediatric brands, SmartMonitor and NeoPAP, to complement its successful portfolio of soft cloth CPAP masks, yet challenging in that the company needed to establish the CE Marking for the new products under the Circadiance brand.

That challenge was met this week a full month ahead of schedule, as Circadiance received a scope extension to its ISO 13485 Certificate as well as the CE Marking for the SmartMonitor and NeoPAP product lines.

The expanded scope of the company’s ISO 13485 certificate allows for the “design, manufacture, and servicing of positive airway pressure therapy devices, masks, tubing, and accessories for continuous positive airway pressure and bi-level therapy, and monitors of respiration, heart rate, and SpO2 levels of infant, pediatric, and adult patients".

“The expansion of scope signifies the advancement of the company’s quality management system and the level of commitment to providing innovative and quality products to our customers,” said Jim Gianoutsos, Manager of Quality Assurance and Regulatory Affairs. “Similarly, CE Marking represents an achievement by all employees of Circadiance and the further expansion of the company into the pediatric and respiratory markets”.

As Dave Groll, CEO of the company stated, “This is a significant milestone for our organization, one which reinforces the high standards that Circadiance consistently achieves relative to its product quality and business processes. We look forward to continuing our leadership role as an innovator in the respiratory space”.

These new approvals allow Circadiance to complete the rebranding of the SmartMonitor and NeoPAP product lines to fully capitalize on the interest that several international distributors have expressed in Circadiance’s pediatric solutions.

Circadiance will display its full line of products to respiratory professionals at the upcoming SLEEP Meeting in
Denver, CO, June 11th-15th
. “Our customers will be impressed with the demonstrated value we bring to the
care of their patients. No other company has the unique respiratory product mix that Circadiance offers” said Jim
Seles, Vice President of Sales and Marketing, who will be attending the event.

About Circadiance:

Circadiance is a pioneer in respiratory therapy specializing in positive airway pressure, non-invasive ventilation and apnea monitoring. Our clinically proven, innovative solutions address patients ranging from premature newborns to frail elderly. Circadiance products deliver superior patient comfort and effectiveness in the acute care and home care settings, ultimately resulting in reduced cost of care and improved outcomes. Circadiance’s brands include the following:

SleepWeaver® – Soft Cloth CPAP Masks

SmartMonitor® – Infant Apnea Monitors

NeoPAP® – Neonatal CPAP and High Flow Respiratory Support System

For more information about Circadiance, contact customer service at (888)-825-9640. International inquiries should call +1-724-858-2837. You can also visit Circadiance.com

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Jim Seles
Circadiance
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