Combining more than 100 years of experience with cutting edge engineering and manufacturing capabilities, Aspenstate has maintained the highest production standards for quality, safety and efficiency, holding an extensive list of accreditations from key global customers, platforms, and standard agencies across various market sectors and geographic regions.
Some of our national and international accreditations are listed below
FDA is a federal agency of the United States Department of Health and Human Services. The systems provided for the U.S market have been registered and hold an FDA 510(K) when applicable.
Health Canada is a department of the government of Canada that is responsible for national public health, which includes the regulation of Medical Devices. The select products that we sell into Canada are all listed with Health Canada.
Cofepris is a regulatory body of the Mexican government that is responsible for regulating a variety of health related topics in Mexico, including medical devices.
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards. The CE marking is recognizable worldwide, and Aspenstate ensures that every system provided into a country requiring CE, has the necessary conformity and corresponding marking on its products.
ISO 13485 is a quality management system for the design and manufacture of medical devices. We have been assessed and found in compliance with ISO 13485:2016. As a result, our facility proudly has this certificate hanging in our front lobby.
Good manufacturing practices are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of various products, including medical devices.
- All systems provided are pre-staged by a certified technician in our Medical ISO 13485 facility in Plano, TX
- We hold & maintain an FDA 510(K), Coefpris, Health Canada, CE, ISO13485, CGMP & required electrical safety tests to sell our products into global markets
- All our technical support members are field-trained, and have the necessary experience to guide our valued dealers to a successful installation