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 regulations. The company also complies with the FDA’s 21 CFR 820 requirements.
ABANZA enhances internal processes to continually increase the quality of customer service and at the same time ensure the quality compliance of our suppliers. Our Quality Manual is used internally to guide our staff through all the necessary requirements that must be met to maintain our Quality System, so we ensure customer satisfaction, continuous improvement, and provide training to create a skilled workforce.
ABANZA works under the highly quality standards set by Medical Device Regulations worldwide in order to provide a great service of its innovative, safe and high-quality products. All of our products are developed and manufactured in full compliance with:
- Applicable ASTM and ISO standards acc. State-of-the-Art.
- European CE Marking requirements.
- FDA requirements and any local legal requirement.
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