Quality

A commitment since day one.

Superior quality is an understatement.

Our approach to quality exceeds the requirements of today’s global market to get products delivered on schedule, within budget, and at the highest level of quality. Working concurrently with our customers, our systems allow us to integrate design and process validations, equipment and tooling qualification, lot traceability, compliance testing and record retention.  Once production processes are qualified, our focus shifts to prevention of defects and continuous growth. Continual growth is achieved through the practices of Lean Manufacturing, Six Sigma, and cost improvement throughout the life of the product.

All aspects of our business strive to achieve superior quality. The continuous creation of value is the excellence that contributes to the success of our customers. All of our employees are responsible and accountable for performing their duties to the high-quality standards of IntriCon.

Certified around the world.

IntriCon has implemented Quality Management Systems that have been certified to the international standards of ISO 13485 and ISO 9001. Our systems are in compliance with the Quality Systems Regulations of the FDA and our proprietary devices bear the CE marking of conformity required for marketing in the European Union. In addition to these, our Singapore facility’s system complies with the Japanese MHLW Ministerial Ordinance No.169, allowing expedient access into the Japanese medical market. Each of our manufacturing facilities is registered with the FDA.

ISO Certifications

To download a copy of our ISO certifications, please click on the links on the right column.