FDA – 510(k) Approval
Westar receives 510(k) approval from the FDA for Medical Devices. Westar devices are determined to be substantially equivalent to legally marketed predicate devices in the industry.
ISO 13485/CMDCAS Certification
Westar receives Certification for conforming to the ISO 13485/CMDCAS International Standard. Westar has met the requirements for a quality management system and has demonstrated the ability to provide medical devices that consistently meet customer and regulatory requirements. ISO aids in streamlining production and increases Safety and Conformity of Westar medical devices.
Canadian Medical Device License issued from Health Canada
In accordance with Canadian Medical Device Regulations, Section 36, Westar becomes licensed to sell medical devices in Canada. ISO 13485/CMDCAS certification enables Westar to meet the Canadian requirements for licensing. Health Canada has deemed Westar products effective and safe to sell in Canada.
New Five Year Warranty, beginning May 2013
We have moved to a better facility:
Westar Medical Products, Inc.
18930 59th Ave. N.E.; Arlington, WA 98223
Phone: 360/435-8900; Fax: 425/328-1544; 800/499-3945