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Quality System

ac.biomed provides quality services.

Therefore, we have implemented our Quality Management to international standards.
Our standard laboratory testing and service documentation are certified to ISO 9001 and compliant to ISO 17025. We have been approved through witness audits by internationally recognized regulatory bodies. Our quality processes are standardized so we can use our energy to serve your project.

Download a copy of our ISO 9001 certification here.

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Quality Methods

Our testing programs are designed to cover all international standards. Our heart valve testing is designed to meet all of ISO 5840 and current FDA heart valve requirements. We offer testing methods for oxygenators, blood pumps and other devices in compliance with international standards and guidelines. Our documentation meets the highest international requirements and is regularly submitted for Notified Bodies and international regulatory agencies such as the US FDA. Our test methods and our robust test equipment are validated from the very beginning. When we develop new methods for our clients, we provide the necessary background information the client needs.

Quality People

Our team is comprised mostly of university-educated biomedical engineers. All of us have worked in industry projects and scientific environments. There is a clear commitment to the quality of our work, from every one of us, every day. Members of our team are part of ISO and IEC international standardization committees.

Our Workflow

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