Circadiance has 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,” according to a company press announcement.
“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.
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.