As a medical device company, CardiacAssist, Inc. is committed to the total, systematic, integrated, consistent, organization-wide approach to Total Quality Management (TQM) as the means to achieve its quality objectives.

People are the key to the company's success. Recognizing people as the major asset, CardiacAssist is promoting a culture of individual excellence involving pride, desire to succeed, attention to detail, teamwork and follow-through.

The company's goal is to implement and operate a Total Quality System that will allow us to provide safe and effective products and services to customers anywhere in the world.

Quality System Achievements

CardiacAssist''s Quality System has been certified by TUV Product Services to meet:

• ISO 13485 Quality Systems - Medical Devices

The TandemHeart System has been tested and meets the requirements of International Standards:

• EN 60601-1 for Medical Electrical Equipment
• CSA C22.2 No 601.1 for Medical Electrical Equipment
• UL 60601-1 for Medical Electrical Equipment

The TandemHeart System bears the CE mark in recognition of meeting the Essential Requirements of the European Union's Medical Device Directive.