The life cycle of medical devices requires highly qualified procedures to guarantee their quality, traceability and integrity. To achieve the highest level of quality and safety for the patient, ABANZA is certified in accordance with the ISO 13485 standard, based on quality specifications related to medical devices, as well as compliance with current regulatory standards. The company also complies with the FDA’s 21 CFR 820 standards.

ABANZA enhances internal processes to continually increase the quality of customer service and at the same time ensure the quality of our suppliers. Our Quality Manual is used internally to guide our employees through the various requirements that must be met and maintained to ensure customer satisfaction, continuous improvement, and provide the necessary instructions to create a skilled workforce.


ABANZA works under the quality standards set by the medical device regulations in order to provide safe and high-quality products.

All of our products are tested and are in compliance with:

  • Lastest ASTM and ISO standards.
  • The requirements of the European Medical Device Directive.