Behind every product: Uncompromising quality
IntriCon has earned a global reputation for quality. We’re known for delivery products on schedule, within budget, and at the highest level of quality. Working closely 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, the focus shifts to the prevention of defects and continuous growth. Lean Manufacturing, Six Sigma, and cost improvement throughout the life of the product is a major factor in IntriCon’s continual growth.
Every employee is responsible and accountable for performing their duties to IntriCon’s high quality standards. They know when we succeed, our customers do, too.
Certified around the world.
We continue to implement 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, our Singapore facility’s system complies with the Japanese MHLW Ministerial Ordinance No.169, allowing expedient access into the Japanese medical market. All of our manufacturing facilities are registered with the FDA.
- IntriCon Minnesota Facilities: ISO 13485:2003
- IntriCon Singapore Facilities: ISO 13485:2016
- IntriCon Singapore Facilities: ISO 9001:2015
- IntriCon Indonesia Facilities: ISO 13485:2016
- IntriCon Indonesia Facilities: ISO 9001:2015
- IntriCon UK Facilities: ISO 9001:2008
- IntriCon UK Facilities: ISO 13485:2003