A Global Provider
As leading global manufacturers, we believe in creating the best products for the best companies. We’re committed to designing, crafting and assembling the best devices on the market. We have strategic relationships with ISO 13485 registered CM's in Asia to help provide the best possible manufacturing solutions.
Datrix was established in 1988 and was incorporated in 1996. In 2017 Datrix was established as an LLC.
ABOUT OUR PRODUCTS
VX3 HOLTER RECORDER
Tradition 5 or 7 wire 3 channel Holter recorder.
The Sirona is truly versatile 4-in 1 device. Traditional event, Post event, Holter, and can be used in any available lead configuration, or with a patch.
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 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, 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 Datrix.
Datrix has implemented Quality Management Systems that have been certified to the international standards of ISO 13485. 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. Our manufacturing facility is registered with the FDA.