Since we are not a manufacturer, ISO Certification and registration does not apply to our organization. Anyone who contracts with us is responsible for maintaining records that demonstrate design control. Our design and documentation process gives us the flexibility to adapt to each of our client's internal system requirements, and it allows us to respond swiftly during all phases of development. Our Quality System follows the model of the International Standards Organization (ISO) 9001, the EN 46001, and the U.S. Food and drug Quality System Regulation (QSR).  Based on our client's requirements, we can reference our Quality Manual and relevant procedures that will inform them about specific controls assuring our quality of service. Read why we choose not to be ISO Registered.