As a USA medical device manufacturer, we must meet the regulatory requirements established by the FDA. Inspectors from the FDA examine our manufacturing facility to verify that we are designing and building safe and reliable products. Armedica is also a certified ISO 13485 Medical Device Manufacturer which means we set and adhere to more stringent manufacturing standards than required by law, formally assuring our customers that we build to a higher quality standard. The ISO inspector visits our plant regularly to not only inspect, but to advise us on methods to improve our processes. ISO certification is not a required certification that we must maintain but a certification that we choose to maintain as formal evidence of our commitment to design, build, and distribute the highest quality product to the industry (at the lowest cost possible).
In summary, when you purchase any Armedica product, you will be purchasing a well designed product, manufactured by skilled and conscientious employees, in a facility located right here in the United States of America .