TRICOR Systems Inc. announced that it had received an ISO 13485 Certificate of Registration issued by NSAI (National Standards Authority of Ireland). The certification ads to TRICOR’s previous certifications and FDA registration.
Elgin, IL. April 10, 2009 — TRICOR Systems Inc., a medical device contract manufacturer of numerous medical devices, today announced that it had received an ISO 13485 Certificate of Registration issued by NSAI (National Standards Authority of Ireland). This certification indicates that TRICOR has implemented a quality system that conforms to the exacting International Organization for Standardization (ISO) standards for medical devices.
ISO 13485 is an internationally recognized standardization system which defines standards for the design, development, production and distribution of medical devices. It ensures conformity with specified quality controls in the development and manufacturing of safe and effective Class I, II and III medical devices.
According to Thomas Allen, Sales Manager for TRICOR Systems, “ISO 13485 certification represents a major milestone for TRICOR and our customers. This certification is one more example of TRICOR’s commitment to the highest quality and process standards allowing TRICOR to better meet the requirements of our medical customers.”
The ISO 13485 certification is added to previous certifications of ISO 9001:2000, and FDA registration improving TRICOR’s already superior standards for meeting customer needs and expectations, including compliance with regulatory requirements.
TRICOR Systems is a privately held electronic contract manufacturing and design facility founded in 1967, located in Elgin, IL USA, providing prototype and production services for a wide range of customers. The company is a high-mix provider of electronics manufacturing services to customers in the medical, defense, aerospace, industrial and instrumentation sectors.
TRICOR has established itself as a mentor to new companies and products entering into the medical equipment field allowing customers to tap into their engineering, manufacturing and exceptional customer service resources.