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. It is recognizable worldwide, and Aspen Imaging Healthcare ensures that every system 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.
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