DOT teams exclusively with the medical device industry, and has dedicated it's 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 towards physicians and patients. 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 continuously 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. 

ISO 13485:2016 Certificate