Dedicated to Medical Devices

Quality

DOT teams exclusively with the medical device industry, and has dedicated its quality systems to meet the unique requirements of 21 CFR Part 820 and applicable international standards.

DOT America’s facility operates under US FDA registration #3011461101, and our quality system is ISO13485:2016 certified through the BSI Group America Inc.

As a company partnering with medical device manufacturers, we recognize our special responsibility toward physicians and patients.

Our Principles

The first class quality of our products and services is essential for the success of our business. In order to attain these quality goals we observe the following principles:

  • We work in accordance with our Quality Management System at all times.
  • We fully comply with our customers’ quality requirements.   
  • We work to continually improve our product and process quality.
  • We strive to purposefully and steadily raise our level of personal qualifications.
  • We promote quality awareness through active coordination within the enterprise.
Our Quality System is
ISO13485:2016 certified.

Customized Surface Processing:

DOT will partner with your R&D team to develop customized surface designs for your specific device application.