Quality System

Regulatory

To enable us to rapidly interact with the ever-changing medical marketplace, we have developed a competency to develop products that meed the needs of our customers.  We are organized to move products through a pipeline.

An adjunct of this product development has been to develop an in-house Regulatory Department in conjunction with FDA Registration and ISO 13485:2003 certification.  This has a dual impact.  We are able to use our ISO 13485:2003 certified process controls to streamline our product development process and facilitate a continuous improvement in the overall operation of our business.

Quality Policy and Core Beliefs   

Our daily efforts will serve as a model for all future regulatory requirements, while always maintaining the quality of our products and services.  The safety and performance of our products is the result of individual commitment and responsibility, contributing to our effective quality system.  Our collective efforts ensure a well planned operational system with all functions of the organization communicating and working together as one.