Tiba Medical Receives ISO13485:2003 Certification

Tiba Medical Earns ISO 13485:2003 Certification

September 1, 2008 – Portland, Oregon Tiba Medical, a provider of non-invasive medical diagnostic systems, today announced that it has received certification from DQS GmbH that its quality management systems are compliant with the international ISO 13485:2003 standard.

Recognized around the world, the ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The ISO13485:2003 is based on eight quality management principles: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact based decision-making and mutually beneficial supplier relationships.

As part of this certification, DQS’ auditors from Germany assessed and audited all aspects of Tiba Medical operations including design, development, manufacturing and customer service to the requirements of ISO 13485:2003 under the European Union’s Medical Device Directive 93/42/EEC and Health Canada’s CMDCAS for medical device manufacturers.

“ISO 13485:2003 certification brings world class status to Tiba Medical, and it provides confidence to our customers through our dedication to quality compliance” said Merat Bagha, President of Tiba Medical. “This certification also opens the door for us to enter markets in the European Union, Canada, Australia, New Zealand and beyond.”

By being ISO13485:2003 certified, and registered by certification body DQS, Tiba Medical’s customers can be certain that the products they have purchased are developed and built within a controlled quality system with a clearer emphasis on documented procedures, policies and quality system objectives as well as requiring top management's support and commitment.

About Tiba Medical

Based in Portland, Oregon, Tiba Medical offers innovative and affordable solutions for noninvasive diagnosis, and monitoring of patients. For more information about Tiba Medical and its products please visit our web site at www.tibamedical.com

About DQS GmbH

Based in Frankfurt, Germany, Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (DQS) provides independent audit, assessment and certification services to nearly 15,000 companies around the world. With more than 1,400 highly qualified and experienced auditors in 50 offices across Europe, North and South America as well as Asia, DQS is a partner for the advancement of management systems.

About ISO

The International Organization for Standards was founded on February 23, 1947 and composed of representatives from various 149 national standards organizations. The organization defines and maintains world-wide industrial and commercial standards. Even though the United States Food and Drug Administration’s (FDA) Quality System Regulations (QSR) are separate, the FDA participated in writing ISO 13485:2003, ensuring that the two are in agreement. Harmonization efforts between the FDA’s QSR and ISO13485:2003 standards are ongoing.

 

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