11.01.07
Xlear, Inc., Orem, UT, has achieved ISO 9001:2000 and ISO 13485:2003 certification for quality management, which is the recognized international standard for medical device regulations around the world. The certifications, awarded by the BSI Group, validate Xlear’s focus on quality and allows the company to market Xlear Nasal Wash around the world as a medical device. In addition, Xlear can now affix CE marking to Xlear Nasal Wash packaging, indicating that it meets the essential health and safety requirements established by the European Union.