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.