This week, Estes Design and Manufacturing, Inc. received its official ISO 13485 certificate, which means its quality management system has been found to demonstrate the ability to design and provide medical devices that consistently meet customer and regulatory requirements. As a trusted partner of leading medical device manufacturers for decades, Estes Design and Manufacturing, Inc. has provided quality and innovative manufacturing and design solutions to its customers.
After months of preparation and adjustment to its existing ISO 9001 quality management system, Estes was able to expand the scope of their certification after a full system audit by DNV-GL auditors in early October resulted in a recommendation for certification. ISO 13485 was constructed to harmonize medical device regulatory requirements for quality management systems and assure that products and services are safe, reliable, and of good quality.
Estes is excited to have qualified its quality management system to ISO 13485 and backed by its engineering staff and state of the art manufacturing facility, stands ready to assist in your medical device design and manufacturing projects.