Westmed is a vertically integrated medical device manufacturing company. We develop, manufacture and market both disposable and reusable anesthesia and respiratory medical devices. Established in 1992, Westmed has experienced consistent growth since its inception by understanding and addressing the changing needs of the healthcare industry.
In 1997 Westmed acquired the patented HEART® continuous nebulizers line from Vortran Medical Technologies. Westmed soon thereafter acquired the assets of Medtrac Technologies, a leader in developing and manufacturing electronic drug compliance and outcomes monitors for respiratory medication delivery systems. These acquisitions positioned Westmed for continued growth and established Westmed as a product leader in the respiratory market.
In 2002 Westmed acquired the assets of Owens-Brigham Medical Company, a diversified manufacturer of anesthesia disposables. This expanded Westmed’s product portfolio to include heated humidification, heated respiratory circuits, arterial blood gas kits, anesthesia circuits, masks and other disposables. This acquisition allowed Westmed to serve both the respiratory and the anesthesia markets.
Today, Westmed employs over 500 people worldwide. Our manufacturing, administration and customer service operations are located in Tucson, Arizona. Additionally, we have two manufacturing facilities located in Mexico, one in Nogales, Sonora and the other in Tecate, Baja California.
The Westmed Quality Management System complies with the requirements and regulations as listed below:
- U.S. Food and Drug Administration (FDA) Regulations including 21 CFR Parts 11, 801, 803, 804, 806, 807, 820, and 830.
- EN ISO 13485:2012; EN ISO 14971
- Canadian Medical Device Regulations, including CMDCAS Requirements
- EU Medical Device Directive 93/42/EEC
- EU IVD Directive 98/79/EC
- Japanese Medical Device QMS, Ministerial Ordinance No. 169
- View / Download ISO 13485 Certificate from MedCert
- View / Download Annex II Certificate from MedCert
Further, all of the Westmed manufacturing facilities in Tucson, Arizona USA; Nogales, Sonora, Mexico and Tecate, Baja California, Mexico are certified by MedCert, EU Notified Body Number 0482. All of the above require assessed compliance to regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for medical use. These requirements are meant to ensure that all medical devices manufactured are safe and effective.