MedRx Inc, Largo, Fla, has been awarded ISO (International Organization for Standardization) 13485 certification for its corporate manufacturing headquarters. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. This accomplishment opens the door to international trade for the company and ensures that there are quality manufacturing, assessment and processing systems in place to ensure consistency regardless of where the products are exported and sold.
According to Ron Buck, president, “We have invested heavily in our process architecture to ensure that we build, test and develop all of our products to meet the highest standard of quality and performance in the industry. Our medical business will be expanding internationally in the coming months, and we will be bringing some new and advanced instrumentation solutions to the world market in the near future.”
[SOURCE: MedRx Inc, August 8, 2006]