PhotoniCare, maker of the OtoSight Middle Ear Scope, announces completion of their ISO 13485:2016 certification.
PhotoniCare, creator of the OtoSight Middle Ear Scope, which allows practitioners to noninvasively visualize through the eardrum to directly assess middle ear fluid, has just announced completion of their ISO 13485:2016 certification. This internationally recognized quality standard specifies the requirements for a quality management system in order to provide the highest level of devices and related services to patients and customers. The Quality Management System PhotoniCare, which services the company's OtoSight MIddle Ear Scope, has been found to meet all requirements of this prestigious certification.
"PhotoniCare's Otosight Middle Ear Scope uses optical coherence tomography to facilitate the diagnosis of acute otitis media," noted Andrew J. Schuman, MD, clinical assistant professor of pediatrics, Geisel School of Medicine at Dartmouth in Lebanon, New Hampshire, and a member of the Editorial Advisory Board of Contemporary Pediatrics®. "Numerous studies have validated its use. Now that the company has achieved this certification, further reassuring providers that the device is worth integrating into a routine practice."