The CardioMed Quality Management System is registered to ISO 13485:2003 as required by the Canadian Medical Devices Conformity Assessment System (CMDCAS) and has been approved in conformity with the requirements of Annex V, section 3.2 - Production quality assurance of Council Directive 93/42/EEC concerning medical devices. In addition, CardioMed is compliant with FDA 21 CFR Part 820 Quality System Regulation. The Quality Management System provides a framework for excellence in product design and development, the quality of our manufactured goods, delivery times, and the elimination of non-value added costs.

Quality Policy

CardioMed produces safe and reliable medical products for the health care industry with consideration given to utmost quality. It is our policy to continuously monitor and indentify our customers' quality needs and promptly meed their expectations today, while concurrently anticipating the requirements of tomorrow.

Quality system management and quality control are vital factors in production and assembly. Cardiomed adheres to the principles of ISO 13485:2003. CardioMed abides by the laws and directives that govern the medical devices industry:

• Health Canada's TPD Medical Devices Directives.
• FDA Subchapter H Medical Devices; Quality System Regulations and GMP.
• Conformity to the European Community's MDD 93/42/EEC Annex V.

CardioMed is committed to highly qualified and trained personnel, and quality is built into every Medical and Health Care product made at CardioMed through our commitment to the finest quality of suppliers.

Quality Documents

Please feel free to download the posted copies of our various quality certifications here. It is suggested that you right click the link and select "Save Target As..." to save the PDF file to your computer.